Executive Director jobs at PTC Therapeutics - 20 jobs

Our Global Market Access (GMAx) organization is dedicated to delivering breakthrough innovations that extend and improve the lives of individuals worldwide. Our focus is on innovation and launch execution excellence, translating scientific advancements into impactful medicines that help people globally. This role presents an exciting opportunity to advance patient access and has a significant impact on fulfilling the company's vision and maximizing the value of its Ophthalmology portfolio. Reporting to the Associate Vice President, Global Market Access, Global Pharma, the **Executive Director, Global Market Access, Ophthalmology** will be a member of the GMAx Pharma leadership team and will lead a team for the Ophthalmology portfolio. The Executive Director, Global Market Access, Ophthalmology will play a leadership role in developing an integrated global market access, pricing and reimbursement strategy for an exciting portfolio of Ophthalmology assets. In this role, the Executive Director will work collaboratively across the enterprise and lead the team in development and execution of global market access strategy and objectives, payer value proposition, pricing strategy, and payer stakeholder communication tools in collaboration with cross-functional teams from Commercial, R&D, Outcomes Research, Medical Affairs, Policy, Communications, and with regional and local market teams. In addition, the role will plan, align and execute with other GMAx teams like Global Pricing and Sustainable Access Solutions. The role requires outstanding leadership to support timely, broad, and sustainable access to our Ophthalmology portfolio and deliver value to our customers. **Primary Responsibilities:** + As an integral part of the Global Pharma leadership team, be actively involved in setting the tone, vision and ambition for the organization and setting an example for what great looks like. + As the Lead of the Ophthalmology team, inspire and coach the team to develop the global payer value proposition, access and pricing strategy for our Ophthalmology portfolio, ensuring access considerations are integrated into global access plans and taking informed positions related to price, value and affordability challenges at the appropriate time of product development and launch. + As a visionary, inform current and future access strategy by synthesizing and communicating payer customer insights, including having oversight of payer market research and analysis of payer landscape and competition. + As a collaborator, ensuring patient access objectives and strategy are linked to clinical development, commercial and value evidence plans by championing the market access vision for the Ophthalmology portfolio in close partnership with cross functional teams including: Marketing and Product Development Teams (PDTs),R&D (ex. clinical, OR and medical affairs), andregional and country access teams. + As a guide for the asset-leads who will lead the Global Access Team (GAT), a strategic platform that facilitates cross-functional collaboration around Access priorities across global teams, key markets and regions. + As the owner of the Access strategy, to bring alignment along with co-leads from OR by providing strategic guidance for the 4th hurdle framework assessments that inform access strategy and evidence generation plans for LCM and pipeline. + As a key resource for regional and country access teams, to prepare for external competitive and environmental pressures with proactive access and negotiation strategies to differentiate and strengthen leadership, including innovative access solutions and contracting. + As a key resource for Business Development, by providing access assumptions for business development assessments on an ad-hoc basis. + As a key resource for Policy, to collaborate in the development of action plans that shape value frameworks and other policies impacting value assessment. + As a Team lead, to build a strong high performing team and coach and develop team members. **Education Minimum Requirement:** + Required: BA/BS + Preferred: Master's degree in business administration, health policy, or health economics **Required Experience and Skills:** + At least 10 years of experience in one or more of these areas: market access, pricing/reimbursement, health policy and/or health economics, sales and marketing (or equivalent roles), market research + Strong understanding of healthcare systems, reimbursement methods, and policy issues, including health technology assessments of major countries + Demonstrated strategic thinking and problem-solving skills + Experience successfully leading cross functional matrix teams + Demonstrated innovative mindset and high level of comfort working in a white space environment that is necessary for innovation + Demonstrated ability to understand, develop and communicate scientific based strategies and messages + Excellent interpersonal skills; strong influencing, negotiating, conflict resolution skills + Comfort and confidence in working with diverse teams and backgrounds; routinely demonstrates inclusive behaviors; actively seeks out diverse perspectives and experiences + Strong commercial orientation and business acumen + Strong verbal and written communications skills + Strong project management and operational skills **Preferred Experience and Skills:** + Knowledge and experience in ophthalmology + Prior experience developing global business strategy + Knowledgeable about health economic tools and techniques + People management experience Travel: Yes, 25% of the time Work Location: Rahway, NJ or Upper Gwynedd, PA (Hybrid) **Required Skills:** Accountability, Accountability, Business Development, Clinical Development, Communication, Communication Tools, Cross-Cultural Awareness, Decision Making, Developing Pricing Strategies, Direct Marketing, Extensive Traveling, Health Economics, Health Technology Assessment (HTA), Interpersonal Relationships, Latin American Markets, Leadership, Market Access, Market Research, Medical Affairs, Ophthalmology, Patient Assistance Programs, People Leadership, Pricing Processes, Product Development, Product Management {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $250,800.00 - $394,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/20/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R375200

Our Finance team brings together our financial perspectives into our overall strategic and tactical decision making. We use state-of-the-art techniques for financial analysis, planning, accounting, reporting and performance evaluation. This allows the organization to continue advancing medical innovation and improve lives. The Executive Director, Financial Planning & Analysis (FP&A) will be a key financial and strategic business partner supporting assigned divisional client organization in our Manufacturing and Research and Development Divisions. The incumbent will lead a team of finance professionals, responsible for forecasting and analytics, supporting both internal and external stakeholders, overseeing monthly close activities, and tracking of actuals. Primary Responsibilities: Provide financial and strategic support to client organization Serve as part of the leadership team of both client and divisional finance organization Partner on strategic as well as tactical fronts to manage the progression of the pipeline with due financial considerations Support the development of robust and realistic financial plans and help articulate those plans in clear and concise manner to the various stakeholders Provide financial support for the formulation and evaluation of capital investment proposals and to help prepare and present the business cases to the various governance bodies Develop and maintain strong relationship and partnership with counterparts across the enterprise to support integrated program views Collaborate seamlessly with various finance and business stakeholders to help advance business goals Have an enterprise mind-set and be able to articulate fully integrated costs and investment considerations and potential trade-offs Provide financial support to pipeline and supply chain and capacity decision making, with the knowledge of key drivers to relevant governance committees Analyze and report actual financial results and to discuss adjustments needed to the projected spend to stay aligned with the approved financial plans Understand operational productivity drivers of the business and to develop/ maintain financial metrics to measure actual performance vs. what's expected Oversee various critical financial processes and to take proactive steps to align with the evolving business needs and ensure that the processes run efficiently and effectively Ensure full compliance with the accounting requirements and maintain sound financial internal control environment Lead and/or to participate in various special initiatives/ projects Lead a team of talented professionals and provide guidance and leadership to the team on various business support aspects Help team members realize their full career aspirations and to proactively seek ways to attract new talent Education: Required: Bachelor's Degree in Business, Finance/Accounting, Science, or Engineering Preferred: MBA or other Masters/PhD in Business, Finance, Science, or Engineering Required Experience and Skills: Minimum of 15 years of operations or Finance experience Effective with Microsoft Office suite (Word, Excel, PowerPoint) Preferred Experience and Skills: Excellent analytical skills and the ability to develop business operations models Strong organizational and time management skills Excellent attention to detail to ensure accurate and on-time deliverables Strong business and financial acumen Demonstrated effectiveness working with teams, including Third Parties Proactive approach to problem solving, including solutions at times may be “outside of the box” Demonstrated ability to influence, build and maintain team, client and peer relationships Excellent interpersonal and communications skills Passion and intellectual curiosity with respect to healthcare industry Experience in the pharmaceutical or healthcare industry Understanding of the drug discovery and development process and/or vaccine and pharmaceutical manufacturing Sufficient knowledge of our company's pipeline/ product line Strong computer skills especially working with SAP, BPC, Power BI, and MS Excel Required Skills: Capital Budgeting, Corporate Financial Planning and Analysis (FP&A), Decision Making, Detail-Oriented, Ethical Compliance, Executive Presence, Financial Analysis, Management Controls, People Leadership, People Performance Management, Pharmaceutical Industry, Preparation of Financial Reports, Relationship Management, Strategic Planning, Variance Analysis Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $210,400.00 - $331,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our Global Market Access (GMAx) organization is dedicated to delivering breakthrough innovations that extend and improve the lives of individuals worldwide. Our focus is on innovation and launch execution excellence, translating scientific advancements into impactful medicines that help people globally. This role presents an exciting opportunity to advance patient access and has a significant impact on fulfilling the company's vision and maximizing the value of its Ophthalmology portfolio. Reporting to the Associate Vice President, Global Market Access, Global Pharma, the **Executive Director, Global Market Access, Ophthalmology** will be a member of the GMAx Pharma leadership team and will lead a team for the Ophthalmology portfolio. The Executive Director, Global Market Access, Ophthalmology will play a leadership role in developing an integrated global market access, pricing and reimbursement strategy for an exciting portfolio of Ophthalmology assets. In this role, the Executive Director will work collaboratively across the enterprise and lead the team in development and execution of global market access strategy and objectives, payer value proposition, pricing strategy, and payer stakeholder communication tools in collaboration with cross-functional teams from Commercial, R&D, Outcomes Research, Medical Affairs, Policy, Communications, and with regional and local market teams. In addition, the role will plan, align and execute with other GMAx teams like Global Pricing and Sustainable Access Solutions. The role requires outstanding leadership to support timely, broad, and sustainable access to our Ophthalmology portfolio and deliver value to our customers. **Primary Responsibilities:** + As an integral part of the Global Pharma leadership team, be actively involved in setting the tone, vision and ambition for the organization and setting an example for what great looks like. + As the Lead of the Ophthalmology team, inspire and coach the team to develop the global payer value proposition, access and pricing strategy for our Ophthalmology portfolio, ensuring access considerations are integrated into global access plans and taking informed positions related to price, value and affordability challenges at the appropriate time of product development and launch. + As a visionary, inform current and future access strategy by synthesizing and communicating payer customer insights, including having oversight of payer market research and analysis of payer landscape and competition. + As a collaborator, ensuring patient access objectives and strategy are linked to clinical development, commercial and value evidence plans by championing the market access vision for the Ophthalmology portfolio in close partnership with cross functional teams including: Marketing and Product Development Teams (PDTs),R&D (ex. clinical, OR and medical affairs), andregional and country access teams. + As a guide for the asset-leads who will lead the Global Access Team (GAT), a strategic platform that facilitates cross-functional collaboration around Access priorities across global teams, key markets and regions. + As the owner of the Access strategy, to bring alignment along with co-leads from OR by providing strategic guidance for the 4th hurdle framework assessments that inform access strategy and evidence generation plans for LCM and pipeline. + As a key resource for regional and country access teams, to prepare for external competitive and environmental pressures with proactive access and negotiation strategies to differentiate and strengthen leadership, including innovative access solutions and contracting. + As a key resource for Business Development, by providing access assumptions for business development assessments on an ad-hoc basis. + As a key resource for Policy, to collaborate in the development of action plans that shape value frameworks and other policies impacting value assessment. + As a Team lead, to build a strong high performing team and coach and develop team members. **Education Minimum Requirement:** + Required: BA/BS + Preferred: Master's degree in business administration, health policy, or health economics **Required Experience and Skills:** + At least 10 years of experience in one or more of these areas: market access, pricing/reimbursement, health policy and/or health economics, sales and marketing (or equivalent roles), market research + Strong understanding of healthcare systems, reimbursement methods, and policy issues, including health technology assessments of major countries + Demonstrated strategic thinking and problem-solving skills + Experience successfully leading cross functional matrix teams + Demonstrated innovative mindset and high level of comfort working in a white space environment that is necessary for innovation + Demonstrated ability to understand, develop and communicate scientific based strategies and messages + Excellent interpersonal skills; strong influencing, negotiating, conflict resolution skills + Comfort and confidence in working with diverse teams and backgrounds; routinely demonstrates inclusive behaviors; actively seeks out diverse perspectives and experiences + Strong commercial orientation and business acumen + Strong verbal and written communications skills + Strong project management and operational skills **Preferred Experience and Skills:** + Knowledge and experience in ophthalmology + Prior experience developing global business strategy + Knowledgeable about health economic tools and techniques + People management experience Travel: Yes, 25% of the time Work Location: Rahway, NJ or Upper Gwynedd, PA (Hybrid) **Required Skills:** Accountability, Accountability, Business Development, Clinical Development, Communication, Communication Tools, Cross-Cultural Awareness, Decision Making, Developing Pricing Strategies, Direct Marketing, Extensive Traveling, Health Economics, Health Technology Assessment (HTA), Interpersonal Relationships, Latin American Markets, Leadership, Market Access, Market Research, Medical Affairs, Ophthalmology, Patient Assistance Programs, People Leadership, Pricing Processes, Product Development, Product Management {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $250,800.00 - $394,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/20/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R375200

Work Your Magic with us! Start your next chapter and join EMD Electronics. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers. Location: The Associate Director for Turnkey Projects is a remote position that requires the candidate to be full-time at the customer jobsite (in North America) during the construction and commissioning phase of the project. During project planning, design stage, procurement stage, the role is primarily remote, with occasional travel to meet internal teams, suppliers, and vendors. There will be approximately 50% domestic and international travel to meet business needs, including staying at construction sites. Your Role: The role demands strong technical acumen, expert project management skills, and leadership in an environment where high-quality, efficient delivery is critical. The Associate Director for Turnkey Projects will be responsible for developing projects and managing project teams in the United States delivering specialty gases and chemical delivery systems in back pads, gas, and chemical buildings and subfabs for semiconductor manufacturing clients. The scope includes proposal work for new business opportunities, development of equipment modulization, leading and executing complex turnkey projects focused on engineering, procurement, construction, and commissioning. The successful candidate will work closely with Sales and Procurement while overseeing multiple project teams, including project managers, engineers, document control engineers, and a project administrator, to ensure projects meet scope, schedule, and budget targets while adhering to rigorous quality and safety standards. Key Responsibilities: As the Associate Director of Turnkey Project Management Team in U.S., you will drive strategy execution, support team growth, manage resources, enhance communication, and align team success with organizational goals. Obtain and maintain commercial general contractor licenses from the states' registrars of contractors. For bidding processes for new EPC (Engineering, Procurement, Construction) projects, analyze customer requirements (RFQ or RFP), review designs, estimate costs, plan schedules, and manage risks. It includes proposing technical solutions that meet customer needs, collaborating with suppliers to select optimal materials and services, and preparing bid documents. Review contract terms, provide competitive pricing, and evaluate project feasibility to secure successful awards. Additionally, manage legal and commercial risks during the bidding process and negotiate with clients to achieve the best outcomes. Interface with semiconductor clients and internal stakeholders to define project scopes, validate technical requirements, and provide strategic updates. Oversee critical engineering deliverables across various disciplines, including process, mechanical, piping, electrical, instrumentation, and control engineering. Responsibilities include reviewing and managing Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), Hazard and Operability Studies (HAZOPs), equipment specifications, plot and layout plans, piping isometrics, single line diagrams, Input/Output (I/O) lists, and logic diagrams. Facilitate design coordination among internal design engineers, subcontractors, vendors, and clients. Develop procurement strategies leveraging professional network and working with procurement manager, coordinating with suppliers and vendors, mitigating risks, ensuring compliance with contractual and regulatory requirements, and fostering collaboration between procurement, engineering, and construction teams to secure timely delivery of materials and equipment critical to project success. Oversee all aspects of construction activities on-site including coordinating with subcontractors, ensuring compliance with safety regulations, resolving on-site issues, and maintaining effective communication with stakeholders to achieve project objectives. Lead cross-functional teams by mentoring and coordinating project managers, engineers, sales personnel, and support staff. Oversee project budgets with forecast and actual cost, resource allocation, scheduling for timelines using Primavera P6 or MS Project, and risk mitigation efforts to ensure timely, on-budget delivery. Ensure compliance with relevant engineering, quality, safety, and regulatory standards throughout project lifecycles. Proactively identify project risks and implement corrective actions; maintain effective communication channels and reporting structures. Champion continuous improvement initiatives by leveraging best practices and advanced project management methodologies. Manage the development of the modularization of equipment such as gas room cabinets, mods, pods, and VMBs to enhance productivity, scalability, and cost-effectiveness. Develop and implement strategies for modular design, ensuring standardization and compatibility across systems. Collaborate with engineering, procurement, and construction teams to optimize designs for transport, assembly, and operation. Oversee the integration of modular units into existing workflows while maintaining quality, safety, and compliance standards. Identify opportunities to reduce project timelines and costs through modular solutions. Provide technical guidance, manage risks, and ensure alignment with project objectives and client requirements. Drive innovation and continuous improvement in modularization practices. Who You Are Minimum Qualifications: Bachelor's degree in chemical engineering, mechanical engineering, electrical engineering, construction management, project management, or a related technical field along with 8+ years of experience in EPC project management within process heavy industries such as semiconductor, oil and gas, petrochemical, refinery, power plant, other plant engineering required. In lieu of a degree, the candidate must have 12+ years of progressive experience in EPC project management, preferably within the semiconductor, oil and gas, petrochemical, refinery, power plant, or other plant engineering required. Strong network of subcontractors and experience in contract negotiation with clients and subcontractors is essential. Eligibility to clear background check required for licensing by states' registrars of contractors. Preferred Qualifications: Preconstruction, project management, engineering management, or design experience in EPC companies related to industrial or specialty gas, semiconductor, oil and gas, petrochemical, refinery, or power plant. Demonstrates respect for individuals and fosters an inclusive work environment that values diversity. Possesses strong cultural awareness and the ability to collaborate effectively with global teams, ensuring mutual understanding and alignment across different perspectives and backgrounds. Preference given to candidates with process, mechanical, piping, electrical and instrument engineering experience, specifically process engineering backgrounds. Proven record of gaining market share by proposing value engineering and winning proposals in projects with intense competition. Experience with preconstruction and proposal preparation of at least ten EPC projects worth more than $50M each. Experience with project execution of at least three EPC projects worth more than $50M each. Extensive experience collaborating with global teams across multiple time zones to achieve project goals and ensure seamless communication along with a proactive and diligent work ethic. Certified Project Management Professional (PMP), MBA, or equivalent certification is strongly preferred. Strong leadership, communication, and problem-solving skills with 10 years of experience in managing cross-functional teams. Familiarity with industry-specific standards and technology related to semiconductor process support. Pay range for this position: $177,200 - $265,800 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

The Associate Director- Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic program leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance. Essential Duties and Responsibilities: Program Leadership and Technical Project Management: Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally. Develop and execute strategic plans for technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality. Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products. Technical Expertise: Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions for medical devices and combination products. Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards. Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governance forums Author and complete regulatory filing sections, and support response to questions and pre-approval inspections from a product development standpoint Stakeholder Collaboration and Communication: Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors. Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs. Build strategic partnerships with manufacturing sites and partner groups Regulatory Compliance and Quality Assurance: Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures. Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems. Qualifications: Education Required Technical BS degree or higher Preferred BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar Experience 8+ years of experience in medical device or combination product engineering. Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems. Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. Exceptional project management skills and principled verbal and written communication abilities, and experience collaborating with combination product development teams and working groups. Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 02/20/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA). Key responsibilities include: 1. Serve as quality oversight for design verification laboratories: Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification. Provides quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA. Ensures procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements Provides support for internal audits and regulatory agency audits. Promotes awareness of applicable regulatory requirements and QMS requirements for design verification laboratories 2. Ensure compliance with data integrity expectations: Leads implementation of ALCOA+ principles for data generated by the design verification laboratories Supports establishment of controls for computer system administration, data archival and data retention 3. Leadership and Personnel Management: Provide strategic direction, mentorship, and development opportunities to personnel Required Education, Experience and Skills: Bachelor of Science in relevant scientific discipline 5 or more years of experience in quality laboratory operations Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills Familiarity with device design verification and design control aspects Experience supporting internal and external audits Required Skills: Biological Analysis, Continuous Improvement Tools, Counterfeit Detection, Good Documentation Practices, Good Laboratory Practices (GLPs), Identifying Customer Needs, Internal Auditing, Lab Equipment Maintenance, Laboratory Analysis, Laboratory Equipment Calibration, Laboratory Operations, Microbiological Analysis, Proper Documentation, Quality Control Management, Quality Management, Quantitative Assay, Regulatory Awareness, Regulatory Compliance, Regulatory Requirements, System Administration, Technical Transfer, Validation Protocols Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/20/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Rahway FLEx (Formulation Laboratory & Experimentation) Center is a flexible, agile facility that brings together capabilities, operations, and talent to accelerate the pipeline. Pharmaceutical Operations & Clinical Supply is seeking applicants for a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage (OSD) GMP development activities on second shift. The successful incumbent will serve as the technical lead for shift production, coordinating safety, quality, and equipment decisions. This role evaluates safety, product/process quality, and equipment performance and determines the appropriate path forward to protect patients, people, and compliance. Key Responsibilities Own technical decisions for the shift and act as the primary production engineering point of contact for Non‑Sterile operations. Evaluate safety, quality, and equipment status; make real‑time technical determinations on next steps, including stop‑work when risk warrants; escalate and document per cGMP expectations. Serve as owner and trainer for key equipment with emphasis on specialty setups (e.g., spray drying, autoinjector assembly, potent‑processing isolators). Lead room readiness and equipment readiness: plan/execute room setup; equipment assembly/disassembly; cleaning; line clearance; changeover. Author, execute, and close GMP documentation (batch records, logs, investigations, CAPA, change controls); ensure data integrity in MES (e.g., PAS‑X) and ALCOA principles. Troubleshoot equipment/system issues and drive root‑cause analysis with peer specialists, formulation scientists, facility engineers, and automation engineers; implement robust corrections/preventive actions. Coach and develop the shift team by actively sharing knowledge, standardizing best practices, and identifying improvements that strengthen safety, quality, delivery, and cost. Lead improvement activities on one of the specialty equipment trains in the oral solid dosage facility Champion Ways of Working and continuous improvement; lead small projects from scoping through qualification and handover. Approves equipment disposition (repair, replace, optimize) based on condition, reliability, and product requirements; coordinates with Maintenance/Facilities, Automation, production, process engineering and formulators. Minimum Qualifications Bachelor's degree in Engineering or Science (e.g., Mechanical, Chemical, Biomedical) or equivalent GMP manufacturing experience. 8+ years in GMP clinical or commercial manufacturing (OSD or specialty dosage forms) with hands‑on equipment setup, cleaning, and troubleshooting. Demonstrated knowledge of cGMP, data integrity, batch documentation, investigations, and CAPA. Experience with OCT, FCT and encapsulation manufacturing; spray dryers, autoinjector assemblies, isolators (OEB4/OEB5), or comparable specialty equipment. Strong problem solving and root‑cause analysis skills; ability to lead and train operators/technicians on the floor. Ability to work second shift on‑site in classified GMP suites. Preferred Qualifications MES experience (e.g., PAS‑X) and proficiency with electronic logbooks and quality systems. Exposure to potent compound handling and containment strategies; respirator/gowning certification a plus. Lean/Six Sigma certification or practical application; familiarity with TPM/RCM and basic reliability tools. Working knowledge of EHS risk assessment (JSA/WRAs) and equipment qualification/validation basics. #PSCS #eligiblefor ERP Required Skills: Accountability, Accountability, Adaptability, Chemical Engineering, Clinical Pharmacy, Corrective Action Management, Customer-Focused, Data-Driven Decision Making, Data Integrity, Dosage Forms, Drug Product Development, Estimation and Planning, GMP Compliance, Innovation, Leadership, Lean Six Sigma (LSS), Manufacturing Engineering, Manufacturing Quality Control, Mechanical Engineering, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Product Formulation, Project Management {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/21/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Associate Director, Compensation Operations is a highly visible role, responsible for leading our ongoing cyclical activities and global initiatives which help evolve our underlying compensation platforms in response to global market conditions. This individual maintains a strong focus on implementation and operational excellence, with ample opportunity to lead (role has two direct reports) and partner with a cross-functional HR network. The ideal candidate is a highly effective consensus builder, strong in the fundamentals of compensation administration and open to new challenges and forward-looking initiatives. This individual plays a critical role in delivering on our company's compensation strategy and executing compensation programs that enable our competitive advantage globally. Primary Responsibilities Provide leadership around the development of compensation-related processes and the integration of compensation structure changes aligned to our CoE's strategy Provide ongoing relevant reporting for all cyclical processes including Annual compensation planning, pay equity and progression promotion Run INSPIRE employee recognition program including supplier management and oversight Support process-related escalations with our global service delivery teams and provide training to effectively support compensation processes Review & approve technical and process-oriented aspects of compensation communications, focusing on change impacts to the organization and our service delivery model Drive the execution and continuous improvement of compensation processes. Maintain and assess the effectiveness of tools available to our stakeholders including our HRBP and global talent acquisition teams to support compensation decision making Provide insight and analytics into user behavior during compensation processes Present material to senior level executives and provide training to global stakeholders on utilization of compensation planning tools; conduct training sessions for end-users Cyclical Activity Oversee end-to-end delivery of all aspects of the annual compensation process with a cross-functional year-end network, including the implementation of compensation strategy changes within Workday's Advanced Compensation environment Lead progression promotion activities and processes across the organization Oversee and coordinate our global pay equity activity with a cross-functional network Establish local and global eligibility requirements related to annual salary increase, bonus, performance ratings and equity awards Facilitate year-round data audits focused on global compensation data integrity Continuously improve compensation processes, with a focus around governance models and solutions that advance the efficiency and effectiveness of self-service Participate in and support M&A projects as needed Qualifications Strong Microsoft Office skills (including advanced Excel and PowerPoint experience) Strong knowledge of global compensation programs Ability to collaborate in a globally matrixed organization Capable of making sound decisions and adapting communications styles to various stakeholder groups with a high degree of conviction Strong functional leadership and problem-solving skills Confident and comfortable in creating and delivering presentations to various levels of the organization Skilled in reporting elements of Workday Advanced analytics capabilities Required Education & Experience Minimum of a bachelor's degree, or currently in pursuit of degree completion, or equivalent relevant work experience. A minimum of 10 years of overall experience in HR or related discipline with 7 years of progressive work experience with broad-based and/or executive compensation programs, and 5 years of experience with Workday Compensation Planning module preferred. (With master's degree, minimum experience is 8 years.) Workday HCM / Workday Advanced Comp knowledge and deployment experience Broad total rewards experience in areas of equity, US benefits and retirement administration is a plus Experience as a project manager is a plus #MSJR Required Skills: Compensation Communications, Compensation Programs, Human Resources (HR), Total Rewards, Workday Advanced Compensation, Workday Compensation Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Reporting to the Director of Packaging Commercialization, the Associate Director, Engineering, Packaging Commercialization will lead packaging development for new oral solid dosage and parenteral products in our small molecule portfolio. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups. The role requires strong technical skills, problem-solving abilities, and the capacity to navigate complex situations in a fast-paced environment, all while aligning packaging with product and patient needs. **Minimum Education Requirement and Experience:** + Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; **OR** + Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience **Required Experience and Skills:** + Small molecule portfolio leadership, with experience supporting small molecule portfolio across oral solid dosage forms (tablets, capsules) + Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components + Demonstrated understanding of the use of Risk Assessment tools + Demonstrated ability to work both independently and as part of a larger team + Demonstrated experience in leading cross-functional groups both internally and externally + Demonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment + Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization + Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging + Strong interpersonal skills and the demonstrated ability to influence senior leaders + Ability to manage complex programs and support multiple activities/projects + Willingness to grow and learn all areas of Pharmaceutical new product development **Preferred Experience and Skills:** + Medical Device and Combination Product Packaging development experience + Quality Risk Management, Risk-Based Decision Making, and Quality by Design (QbD) experience + Experience in defining standard work processes and documents. + Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard and recyclables. **Required Skills:** Compliance Packaging, Cross-Functional Teamwork, Engineering Standards, Good Manufacturing Practices (GMP), Leadership, Packaging Engineering, Packaging Processes, Pharmaceutical Development, Process Optimization, Project Management, Root Cause Analysis (RCA), Small Molecules, Technical Leadership **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/28/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381108

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: This position will have strategic responsibility for a global Start-up Solution Unit Lead focused on Clinical Site Agreements (CSA). You operate in a matrixed environment supporting the review and execution of agreements with the Institutions and Investigators involved in our Clinical Trials. You will be responsible to review and manage legal and budget escalations related to different type of agreements, collaborating with internal and external stakeholders across multiple Countries with the final goal to support contract execution and the delivery of the site activation strategy as per best-in-class benchmarks. Additional responsibilities will include leading, developing and updating negotiating parameter guidance documents at Country and Site level; approving Fair Market Value (FMV) assessments and performing CDA customization across the portfolio, leading discussion with Legal where required. Who You Are Minimum Qualifications: Medical or Life Sciences degree or equivalent qualifications At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment Understanding of the overall clinical development paradigm, especially around clinical study operations and have global or regional experience. Has 5 or more years of experience in contract and budget negotiation Experience in oversight of external service providers, preferred Location: Remote, Boston MA or east coast preferred Pay range for this position: $125,000 - $187,400. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

The Associate Director, Site and Monitoring Health will provide strong leadership, GCP expertise and clinical operations experience to drive the monitoring strategy for trials in their assigned program(s). They are responsible for co-directing (in a matrix environment) the extended team to safeguard the quality of clinical trial execution at investigator sites and ensure Alnylam's oversight of CRO monitoring effectiveness. The Associate Director, Site and Monitoring Health will line manage and matrix manage Site and Monitoring Health staff and direct the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Site and Monitoring Health or above. Summary of Key Responsibilities * Develop, implement, and oversee Alnylam's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8, ensuring that monitoring plans for trials assigned reflect the strategy and the trial budget is aligned. * Lead, direct, and support Site and Monitoring Health Leads in assessing CRO monitoring effectiveness across the portfolio. * Direct day-to-day work activities for FSP Vendor Site and Monitoring Health Leads * Liaise with CRO partners and internal partners (including Clinical Risk & Analytics and Study Management) to ensure overall understanding of monitoring strategy and alignment among trial plans. * Consistently manage oversight activities at the program level as aligned and ensure Study Specific Oversight Plans are appropriately implemented and followed for all studies within scope. * Drive a culture that balances purposeful urgency with passion for excellence, employ risk-based thinking to focus on what is critical to quality, and emphasize an "inspection ready at all times" mentality. * Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations' goals. * Assist in planning and trial optimization to evolve the Clinical Operations organization as we scale for the future. * Participate in various workstreams and projects as a leader in Clinical Operations to improve and refine processes. * Ensure Site and Monitoring Health Leads complete administrative tasks on time and facilitate their continuous development. * Determine resourcing needs within Site and Monitoring Health and workload allocation based on the portfolio. * Support inspection preparation and management. * Maintain awareness of changes in industry and regulatory standards for GCP requirements and share updates with Site and Monitoring Health Team * Travel (including occasional global travel) averages Requirements * Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred * Previous experience in Sponsor Oversight, Site and Monitoring Health, RBQM+, and Line Management preferred * Proven experience in effectively leading teams and regional remote-based staff * Solid direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/CRA management experience preferred * Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred * Previous regulatory inspection experience preferred * Comprehensive and current regulatory knowledge, including GCPs Skills * Ability to concisely present significant issues and criticality to senior leaders * Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions * Ability to build and maintain relationships with key investigators and sites (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff * Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve * Experience with Microsoft based applications and ability to learn internal computer systems * Effective leader and collaborator with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment * Effectively manage and develop others to be successful at Alnylam and meet the needs of Clinical Trial Oversight and the broader organization * Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups * Demonstrate good judgment and decision-making experience * Ability to delegate tasks and oversee delegated activities U.S. Pay Range $165,300.00 - $223,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ******************************* About Alnylam We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

+ The Associate Director, Scientific Patient Engagement and Advocacy Lead, General/Specialty Medicineis responsible for developing and implementing a global headquarters strategic patient engagement plan aligned with therapeutic objectives ensuring the patients' perspectives remain central to the work of our company. The Scientific Patient Engagement Lead manages and enables the planning and execution of patient engagement initiatives and manages relationships between patient advocacy organizations (PAOs) and our Company. This position coordinates with both internal and external stakeholders, gathers insights, and includes patient input into clinical research, V&I, commercial, policy, and manufacturing plans. + The Scientific Patient Engagement and Advocacy Lead will drive/execute the patient engagement and advocacy strategy in alignment with company priorities, work cross-functionally with various internal teams and externally with patients, advocates and PAOs to coordinate and cascade expertise. This Leader is innovative, collaborative, strategic, compassionate, and can lead directly and indirectly through influence. **Responsibilities and Primary Activities** + Develops the headquarters therapeutically aligned strategic plan, executes strategic initiatives and assists in planning of key performance indicators (KPI), goals and tactics that flow from evolving Value and Implementation priorities, and internal and external factors + Executes and implements patient innovation and engagement activities through incorporation of the patient voice into internal strategy development and decision-making across our company + Supports efforts to gather and include patients' and advocates insights and perspectives throughout the product lifecycle + Develop the headquarters therapeutically aligned strategic patient advocacy and educational plans + Develop, manage, and support long-term PAO relationships through engagement and communication + Serve in a liaison function to PAOs and patient arms of professional societies + Facilitate engagement through active participation at national and regional congresses and successful implementation of meetings with PAO leadership and executive staff. + Ensure compliance with existing company guidelines as they pertain to patient advocacy + Navigates across internal and external stakeholders ranging from individual patients to highly networked patients and medical organizations + Collaborates with key internal stakeholders to proactively develop and execute the global Value and Implementation plan + Participates in external conferences, congresses, and industry consortiums to represent our company's focus on the patient including speaking, presenting and authoring publications. + Ensures alignment with regional and country level related activities (patient, scientific, medical) + Supports any division with needs relating to patient engagement or patient advocacy, including our Company's Research Labs, Human Health, our Company's Manufacturing division, IT, and others + Develops the talent on the team and seeks opportunities to enhance their capabilities + Tracks associated spend for activities and communicates with TA and Strategy Lead + Tracks and reports impacts, findings and associated key metrics and measurements related to work **Key Internal Stakeholders:** Patient Innovation and Engagement Center of Excellence Therapeutic Area Leadership Global Policy and Corporate Communications Teams US Federal Policy & Government Relations State Government Affairs & Policy our Company's Research & Development division, Value & Implementation Human Health, our Company's Manufacturing division, IT Global Medical Proficiency and External Affairs (GMPEA) Global Clinical Development (GCD) **Required Qualifications, Skills, & Experience** **Minimum** + Advanced Degree in health sciences -OR- equivalent level of patient engagement work experience [MD, MSN, or PhD strongly desirable] + Minimum of 5 years' experience in the healthcare industry (clinical/biopharmaceutical/patient advocacy organization, etc.) + Minimum of 2 years' experience managing relationships with external stakeholders. + Deep academic understanding of the science of patient input and a strong record of achievement obtaining and incorporating patient insights into decision making + Deep understanding of Patient Engagement, Patient Insights, Patient Advocacy Organizations, as well as knowledge of best practices in those areas + U.S./Global experience in clinical research, regulatory affairs, scientific and medical affairs, or pharmaceutical policy + Ability to understand the importance of patient innovation and engagement across our Company + Record of advocating or advancing patient engagement experience + Ability to navigate a complex matrixed organization, think creatively, and develop innovative strategies and solutions + Ability to understand and manage a diverse set of issues and engage with a diverse, complex group of stakeholders + Ability to manage competing priorities with effective collaboration and program management skills + High degree of ethics and ability to build effective working relationships, both internally and externally **Other Personal Characteristics** + Scientific and medical credibility to represent the company to patients, patient advocates, patient organizations and medical and scientific organizations + Ability to work in a complex organization and to effectively operate in a team-oriented structure + Excellent interpersonal communication (written as well as oral), results-oriented project management, facilitation, and consultative skills to influence decision making are required + Compassionate communicator skilled in empathetic listening and navigating sensitive patient conversations + Experience managing interactions with senior leaders, ability to work well as a team member + Ability to travel, 15-20% anticipated **Preferred** + Prior experience working with patients and PAOs strongly desired + Experience in the therapeutic area space strongly desired + Demonstrated track record of establishing trusted and meaningful relationships with patient organizations and with professional society or public health organizations and their leaders strongly preferred **Required Skills:** Partner Relationship Management (PRM), Patient Advocacy, Patient Engagement, Patients Rights, Pharmaceutical Medical Affairs, Project Facilitation, Project Management, Scientific Communications, Stakeholder Relationship Management **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381462

+ The Associate Director, Scientific Patient Engagement and Advocacy Lead, General/Specialty Medicineis responsible for developing and implementing a global headquarters strategic patient engagement plan aligned with therapeutic objectives ensuring the patients' perspectives remain central to the work of our company. The Scientific Patient Engagement Lead manages and enables the planning and execution of patient engagement initiatives and manages relationships between patient advocacy organizations (PAOs) and our Company. This position coordinates with both internal and external stakeholders, gathers insights, and includes patient input into clinical research, V&I, commercial, policy, and manufacturing plans. + The Scientific Patient Engagement and Advocacy Lead will drive/execute the patient engagement and advocacy strategy in alignment with company priorities, work cross-functionally with various internal teams and externally with patients, advocates and PAOs to coordinate and cascade expertise. This Leader is innovative, collaborative, strategic, compassionate, and can lead directly and indirectly through influence. **Responsibilities and Primary Activities** + Develops the headquarters therapeutically aligned strategic plan, executes strategic initiatives and assists in planning of key performance indicators (KPI), goals and tactics that flow from evolving Value and Implementation priorities, and internal and external factors + Executes and implements patient innovation and engagement activities through incorporation of the patient voice into internal strategy development and decision-making across our company + Supports efforts to gather and include patients' and advocates insights and perspectives throughout the product lifecycle + Develop the headquarters therapeutically aligned strategic patient advocacy and educational plans + Develop, manage, and support long-term PAO relationships through engagement and communication + Serve in a liaison function to PAOs and patient arms of professional societies + Facilitate engagement through active participation at national and regional congresses and successful implementation of meetings with PAO leadership and executive staff. + Ensure compliance with existing company guidelines as they pertain to patient advocacy + Navigates across internal and external stakeholders ranging from individual patients to highly networked patients and medical organizations + Collaborates with key internal stakeholders to proactively develop and execute the global Value and Implementation plan + Participates in external conferences, congresses, and industry consortiums to represent our company's focus on the patient including speaking, presenting and authoring publications. + Ensures alignment with regional and country level related activities (patient, scientific, medical) + Supports any division with needs relating to patient engagement or patient advocacy, including our Company's Research Labs, Human Health, our Company's Manufacturing division, IT, and others + Develops the talent on the team and seeks opportunities to enhance their capabilities + Tracks associated spend for activities and communicates with TA and Strategy Lead + Tracks and reports impacts, findings and associated key metrics and measurements related to work **Key Internal Stakeholders:** Patient Innovation and Engagement Center of Excellence Therapeutic Area Leadership Global Policy and Corporate Communications Teams US Federal Policy & Government Relations State Government Affairs & Policy our Company's Research Labs, Value & Implementation Human Health, our Company's Manufacturing division, IT Global Medical Proficiency and External Affairs (GMPEA) Global Clinical Development (GCD) **Required Qualifications, Skills, & Experience** **Minimum** + Advanced Degree in health sciences -OR- equivalent level of patient engagement work experience [MD, MSN, or PhD strongly desirable] + Minimum of 5 years' experience in the healthcare industry (clinical/biopharmaceutical/patient advocacy organization, etc.) + Minimum of 2 years' experience managing relationships with external stakeholders. + Deep academic understanding of the science of patient input and a strong record of achievement obtaining and incorporating patient insights into decision making + Deep understanding of Patient Engagement, Patient Insights, Patient Advocacy Organizations, as well as knowledge of best practices in those areas + U.S./Global experience in clinical research, regulatory affairs, scientific and medical affairs, or pharmaceutical policy + Ability to understand the importance of patient innovation and engagement across our Company + Record of advocating or advancing patient engagement experience + Ability to navigate a complex matrixed organization, think creatively, and develop innovative strategies and solutions + Ability to understand and manage a varied set of issues and engage with a varied, complex group of stakeholders + Ability to manage competing priorities with effective collaboration and program management skills + High degree of ethics and ability to build effective working relationships, both internally and externally **Other Personal Characteristics** + Scientific and medical credibility to represent the company to patients, patient advocates, patient organizations and medical and scientific organizations + Ability to work in a complex organization and to effectively operate in a team-oriented structure + Excellent interpersonal communication (written as well as oral), results-oriented project management, facilitation, and consultative skills to influence decision making are required + Compassionate communicator skilled in empathetic listening and navigating sensitive patient conversations + Experience managing interactions with senior leaders, ability to work well as a team member + Ability to travel, 15-20% anticipated **Preferred** + Prior experience working with patients and PAOs strongly desired + Experience in the therapeutic area space strongly desired + Demonstrated track record of establishing trusted and meaningful relationships with patient organizations and with professional society or public health organizations and their leaders strongly preferred **Required Skills:** Medical Affairs, Partner Relationship Management (PRM), Patient Access, Patient Engagement, Patient Interactions, Patient Relations, Patients Rights, Patient Support, Pharmaceutical Medical Affairs, Project Management, Stakeholder Management **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381467

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot, small- and large-scale potent material handling, and the ability to integrate new technologies and cell-line platforms. The Facility & Utilities Engineering Lead will be a member of the Engineering & Automation leadership team and will report to the Head of Engineering & Automation for NGB. Job Responsibilities: Lead the Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations. Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration. Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off-hours, weekends and holidays coverage. Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements. Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns to maintain robust building operations. Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc. Drive continuous improvement programme across all areas - safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence. Manage a team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies. Support facility and utilities assessment for New Product Introduction, as required. Support Energy Management, Environmental Sustainability & Business Continuity activities through data. Accountable for delivery of Engineering spend within approved budget. Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA). Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan. Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed. Required Education, Experience and Skills: Education: Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master's degree with minimum 6 years of relevant experience. Experience & Skills: Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. Prior experience of team management and monitoring performance Possess a deep understanding of a facilities and engineering management in GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of clean utilities systems. Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations. Ability to perform technical analysis to drive continuous improvement and overall efficiency. Preferred Experience and Skills: Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team Track record of working effectively with team-members of diverse skill sets and backgrounds Excellent troubleshooting and problem-solving skills and the ability to overcome technical and organizational challenges Delta V and MES (Manufacturing Execution System) knowledge and experience Strong verbal and written communication skills, and attention to detail Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering. Proven self-motivation, ability to drive improvements, and inspire others. Demonstrated ability to work effectively as part of diverse teams. Ability to challenge the status quo with a continuous improvement mindset. Strong leadership ability and collaborative skills. Strong analytical and presentation skills. Ability to lift 25 lbs, if required. #PRD Required Skills: API Manufacturing, API Manufacturing, Applied Engineering, Business Continuity, Change Control Systems, Chemical Process Development, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Employee Development, Equipment Qualification, Facility Management, GMP Compliance, Immunochemistry, Leadership, Management Process, Manufacturing Processes, Manufacturing Process Validation, Microbiology, Operational Excellence, People Leadership, Pharmaceutical Sciences, Process Optimization, Regulatory Inspections, Regulatory Requirements {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/31/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot, small- and large-scale potent material handling, and the ability to integrate new technologies and cell-line platforms. The Facility & Utilities Engineering Lead will be a member of the Engineering & Automation leadership team and will report to the Head of Engineering & Automation for NGB. **Job Responsibilities:** + Lead the Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations. + Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration. + Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off-hours, weekends and holidays coverage. + Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements. + Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns to maintain robust building operations. + Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc. + Drive continuous improvement programme across all areas - safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence. + Manage a team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies. + Support facility and utilities assessment for New Product Introduction, as required. + Support Energy Management, Environmental Sustainability & Business Continuity activities through data. + Accountable for delivery of Engineering spend within approved budget. + Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA). + Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan. + Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed. **Required Education, Experience and Skills:** **Education:** Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master's degree with minimum 6 years of relevant experience. **Experience & Skills:** + Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems. + Prior experience of team management and monitoring performance + Possess a deep understanding of a facilities and engineering management in GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of clean utilities systems. + Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations. + Ability to perform technical analysis to drive continuous improvement and overall efficiency. **Preferred Experience and Skills:** + Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team + Track record of working effectively with team-members of diverse skill sets and backgrounds + Excellent troubleshooting and problem-solving skills and the ability to overcome technical and organizational challenges + Delta V and MES (Manufacturing Execution System) knowledge and experience + Strong verbal and written communication skills, and attention to detail + Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering. + Proven self-motivation, ability to drive improvements, and inspire others. + Demonstrated ability to work effectively as part of diverse teams. + Ability to challenge the status quo with a continuous improvement mindset. + Strong leadership ability and collaborative skills. + Strong analytical and presentation skills. + Ability to lift 25 lbs, if required. \#PRD **Required Skills:** API Manufacturing, API Manufacturing, Applied Engineering, Business Continuity, Change Control Systems, Chemical Process Development, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Employee Development, Equipment Qualification, Facility Management, GMP Compliance, Immunochemistry, Leadership, Management Process, Manufacturing Processes, Manufacturing Process Validation, Microbiology, Operational Excellence, People Leadership, Pharmaceutical Sciences, Process Optimization, Regulatory Inspections, Regulatory Requirements {+ 4 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** No Travel Required **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/31/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R378655

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Technical Operations - Engineering Lead is responsible for leading the equipment engineering team and providing technical leadership across aseptic manufacturing operations at the FLEx Sterile Rahway site. This role is a facility-facing technical leader, independent of product, and focuses on ensuring consistent and reliable production across programs on our aseptic formulation, sterile filling/lyophilization, sterile supply, and visual inspection processes. This role also owns process knowledge, oversight of process improvements, and compliance-critical technical deliverables. The leader will partner closely with Manufacturing, Quality, Development, and external partners to enable reliable supply, qualification of equipment and materials, and continuous improvement of sterile drug product processes. Off-shift (2nd) work and overtime will intermittently be expected as a part of the role to support operations areas. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS). Key Responsibilities: Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products as they are processed through formulation and aseptic fill/finish. Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, raw materials, and processes for clinical and commercial production. Build and maintain a high-performing staff of engineers to support ongoing production and process transfers. Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners. Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards. Perform trending and monitoring of critical attributes to maintain equipment health and control process drift. Identify and implement process improvements in collaboration with manufacturing operations. Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports). Lead investigations with Manufacturing, Quality, and other business units to determine root causes for variations, implement solutions, and ensure corrective actions are effective. Collaborate with other departments on manufacturing-related issues to resolve problems and support organizational goals. Own the process, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process. Perform other related duties as assigned. Education Minimum Requirements: Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years of relevant experience, or a PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years of relevant experience. Required Experience and Skills: Excellent interpersonal and communication skills, both verbal and written. Expertise in drug product aseptic processing, equipment, and sterile technique. Experience in leading quality investigations and change management. Familiarity with United States and European Union GMP and Safety compliance regulations. Lean Six Sigma Experience Ability to prepare Standard Operating Procedures (SOP) and current GXP documents. Experience with quality systems. Excellent organizational skills. Desire and willingness to learn, contribute and lead. Track-record of independent problem-solving. Preferred Experience and Skills: Experience with sterile GMP facility startup. Knowledge of Investigational drug regulatory requirements. Black Belt Certification #PSCS #eligiblefor ERP Required Skills: Accountability, Accountability, Business Acumen, Chemical Engineering, Chemistry, Conducting Experiments, Corrective Action Management, Cross-Functional Teamwork, Engineering Principle, Engineering Standards, Estimation and Planning, Experimental Methods, GMP Compliance, Identifying Customer Needs, Innovation, Leadership, Maintenance Supervision, Managing Engineering Teams, Manufacturing Processes, Manufacturing Scale-Up, Pharmaceutical Sciences, Production Improvement, Production Support, Regulatory Compliance, Report Writing {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/20/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). A large-scale capital project, known as the FLEx Sterile Expansion project, is currently underway. The FLEx Sterile Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning and qualification of the long lead time process equipment. Upon its completion, the expansion project will more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and various supporting infrastructure and utilities. As we prepare to bring this asset online, we are seeking an Associate Director, Operations to lead the end-to-end operational strategy, execution, and performance of the facility. This leader will shape the operational culture from the ground up, ensuring the site is staffed with exceptional talent, achieves operational readiness on an aggressive timeline, and continuously delivers operational excellence in a highly regulated, patient-centric environment. Early on, this leader will partner closely with engineering, quality, validation, EHS, supply chain, and program teams to align operational needs with the C&Q plan, ensuring equipment, utilities, cleanrooms, and process areas are fit for use and ready for clinical manufacturing campaigns. They will establish the operating model, define core processes, and set performance standards that meet cGMP, aseptic processing, and safety requirements. In parallel, the Associate Director, Operations will design and execute a comprehensive hiring and staffing plan, recruiting and developing a high-performing team across production, scheduling, and operations support. They will craft role profiles, training curricula, and competency frameworks that enable a robust, compliant operation and foster a culture of accountability, continuous learning, and right-first-time execution. This leader will be deeply involved in onboarding and capability building, ensuring operators and support staff are confident in aseptic behaviors, gowning, environmental monitoring awareness, batch record execution, and deviation prevention. As the facility transitions from C&Q into routine operations, the Associate Director, Operations will own operational readiness. This includes approval and deployment of SOPs, master production schedules, visual factory and tiered daily management, material flow and warehousing strategies, production planning and finite scheduling, line-clearance and batch-release coordination, and readiness drills for aseptic interventions and media fills. They will drive readiness of EM programs, cleaning and disinfection procedures, equipment maintenance plans, and tech transfer playbooks, partnering with technical operations, quality, and engineering to ensure process robustness and compliant execution. Operational excellence will be the hallmark of this role. The Associate Director, Operations will implement a performance system grounded in safety, quality, delivery, cost, and people metrics-leveraging lean methodologies, problem-solving, and statistical thinking to reduce variability, elevate yield, and prevent defects. They will champion digital tools and data-driven decision-making, deploy right-sized standard work, and lead kaizen events to continuously improve throughput and reliability. This leader will own the short- and long-range capacity plans, align resources to clinical portfolio needs, and ensure predictable, on-time delivery of clinical batches with impeccable GMP compliance for the filling line asset in scope of the expansion project. Key Responsibilities Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development. Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns. Establish and maintain GMP-compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations. Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills. Lead daily operations post-authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers. Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement. Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing. Drive cross-functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments. Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities. Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact. What Success Looks Like Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills and audit readiness activities. A fully staffed and trained operations team performs with high reliability, compliance, and morale. Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter-over-quarter. Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes. Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety. Provide manufacturing and operational expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection. Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Bringing in appropriate stakeholders when required. Conduct all work activities with strict adherence to the safety and compliance culture on site. Support the authoring of electronic batch records, sampling plans, and standard operating procedures. Education Minimum Requirements: Bachelor's degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience. Master's degree with 6 years of relevant experience, or a PhD degree with 4 years of relevant experience. Required Experience and Skills: Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred. Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent. In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements. Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership. Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans. Preferred Experience and Skills: Hands-on experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations. Experience applying consultative skills: ability to influence decision making, ability to interact with all levels of the business (senior leaders to shop floor working teams). Project management skills (demonstrated experience in managing large project teams). Ability to Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary. The role is based out of our Corporate Headquarters in Rahway, New Jersey and reports to the Enabling Technologies lead within Pharmaceutical Operations and Clinical Supply. Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Applied Engineering, Aseptic Operations, Capability Development, Capital Projects, Communication, Decision Making, GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Leadership, Lean Manufacturing, Lean Six Sigma Process Improvement, Management Process, Manufacturing Quality Control, Materials Flow, Operational Excellence, Operations Support, Packaging Processes, People Leadership, Pharmaceutical Sciences, Process Improvements, Production Management, Production Planning {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 02/8/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). A large-scale capital project, known as the FLEx Sterile Expansion project, is currently underway. The FLEx Sterile Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning and qualification of the long lead time process equipment. Upon its completion, the expansion project will more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and various supporting infrastructure and utilities. As we prepare to bring this asset online, we are seeking an Associate Director, Operations to lead the end-to-end operational strategy, execution, and performance of the facility. This leader will shape the operational culture from the ground up, ensuring the site is staffed with exceptional talent, achieves operational readiness on an aggressive timeline, and continuously delivers operational excellence in a highly regulated, patient-centric environment. Early on, this leader will partner closely with engineering, quality, validation, EHS, supply chain, and program teams to align operational needs with the C&Q plan, ensuring equipment, utilities, cleanrooms, and process areas are fit for use and ready for clinical manufacturing campaigns. They will establish the operating model, define core processes, and set performance standards that meet cGMP, aseptic processing, and safety requirements. In parallel, the Associate Director, Operations will design and execute a comprehensive hiring and staffing plan, recruiting and developing a high-performing team across production, scheduling, and operations support. They will craft role profiles, training curricula, and competency frameworks that enable a robust, compliant operation and foster a culture of accountability, continuous learning, and right-first-time execution. This leader will be deeply involved in onboarding and capability building, ensuring operators and support staff are confident in aseptic behaviors, gowning, environmental monitoring awareness, batch record execution, and deviation prevention. As the facility transitions from C&Q into routine operations, the Associate Director, Operations will own operational readiness. This includes approval and deployment of SOPs, master production schedules, visual factory and tiered daily management, material flow and warehousing strategies, production planning and finite scheduling, line-clearance and batch-release coordination, and readiness drills for aseptic interventions and media fills. They will drive readiness of EM programs, cleaning and disinfection procedures, equipment maintenance plans, and tech transfer playbooks, partnering with technical operations, quality, and engineering to ensure process robustness and compliant execution. Operational excellence will be the hallmark of this role. The Associate Director, Operations will implement a performance system grounded in safety, quality, delivery, cost, and people metrics-leveraging lean methodologies, problem-solving, and statistical thinking to reduce variability, elevate yield, and prevent defects. They will champion digital tools and data-driven decision-making, deploy right-sized standard work, and lead kaizen events to continuously improve throughput and reliability. This leader will own the short- and long-range capacity plans, align resources to clinical portfolio needs, and ensure predictable, on-time delivery of clinical batches with impeccable GMP compliance for the filling line asset in scope of the expansion project. **Key Responsibilities** + Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development. + Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns. + Establish and maintain GMP-compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations. + Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills. + Lead daily operations post-authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers. + Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement. + Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing. + Drive cross-functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments. + Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities. + Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact. **What Success Looks Like** + Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills and audit readiness activities. + A fully staffed and trained operations team performs with high reliability, compliance, and morale. + Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter-over-quarter. + Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes. + Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety. + Provide manufacturing and operational expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection. + Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Bringing in appropriate stakeholders when required. + Conduct all work activities with strict adherence to the safety and compliance culture on site. + Support the authoring of electronic batch records, sampling plans, and standard operating procedures. **Education Minimum Requirements:** + Bachelor's degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience. + Master's degree with 6 years of relevant experience, or a + PhD degree with 4 years of relevant experience. **Required Experience and Skills:** + Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred. + Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent. + In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements. + Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership. + Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans. **Preferred Experience and Skills:** + Hands-on experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations. + Experience applying consultative skills: ability to influence decision making, ability to interact with all levels of the business (senior leaders to shop floor working teams). + Project management skills (demonstrated experience in managing large project teams). + Ability to Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary. The role is based out of our Corporate Headquarters in Rahway, New Jersey and reports to the Enabling Technologies lead within Pharmaceutical Operations and Clinical Supply. **Required Skills:** Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Applied Engineering, Aseptic Operations, Capability Development, Capital Projects, Communication, Decision Making, GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Leadership, Lean Manufacturing, Lean Six Sigma Process Improvement, Management Process, Manufacturing Quality Control, Materials Flow, Operational Excellence, Operations Support, Packaging Processes, People Leadership, Pharmaceutical Sciences, Process Improvements, Production Management, Production Planning {+ 4 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic/International **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 02/8/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R377459

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: ************** Summary: The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation. She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues. The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. .Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities: Ensure the data collected meets the requirements of the study objective and company quality standards. Assist in the development and implementation of strategic vision for data management (DM) group. Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end. Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis. Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation and lock activities. Lead development of data management plans, data review plans, supervise database development, and reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data. Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc. Participate in cross functional team meetings, as requested, and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs. Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data. Develop and update SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs. Participate in clinical review and validation of statistical outputs used in the preparation of final reports. Mentor clinical team members by resolving problems and providing DM guidance. Manage multiple and varied tasks, prioritize workload with attention to detail. Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team. Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities. Lead the completion of data management activities to meet project timelines and communicate status to respective team members. Contribute to the development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement. May manage, coach, and mentor direct reports. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience. Bachelor's degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions. * Special knowledge or skills needed and/or licenses or certificates required. Experience in second-line management and functional leadership. Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies. Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages. Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines. Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.). Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills. Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects). Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.). Learning agility and ‘scalability' to take on increasing responsibility Excellent time management, flexibility, ability to coordinate workload and meet established deadlines. Ability to influence without direct authority. Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. Minimum five (5) years' experience with Medidata RAVE(EDC, R2DS/RBS, Architect). Experience with Medidata RAVE. Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience. Experience in PL/SQL, SAS, Java, C++ relational database design and database programming skills preferred. * Travel requirements 5- 15% Expected Base Salary Range $149,100 - $187,700. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. #LI-NM1 EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page