A leading pharmaceutical company in Boston is seeking an experienced Associate Director to lead training initiatives within the Oncology team. The role involves developing comprehensive training programs and collaborating with sales leaders to enhance team capabilities. Candidates should have a strong background in pharmaceutical sales, preferably in oncology, along with leadership and project management skills. This position offers a competitive salary and a hybrid work environment.
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$112k-207k yearly est. 4d ago
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Director, New Product Planning and Business Development Forecasting, Global Oncology
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description Director, New Product Planning and Business Development Forecasting, Global Oncology Takeda Pharmaceutical Cambridge, MA About the role:
The Director will be a key strategic though partner to the business development and new product planning teams in creating forecasts for pipeline assets and Business Development (BD) opportunities within Takeda's Oncology Business Unit (OBU).
The individual will perform strategic market analysis for pipeline assets and BD opportunities through the integration of secondary healthcare data analytics, competitive intelligence, and primary market research, and other data inputs to create quantitative insights and facilitate key business decisions. As part of this role, the individual will be interacting regularly with working with cross functional team across commercial, clinical, medical, and access/pricing teams to perform asset evaluations.
The individual will be interacting with senior leadership of the Oncology business unit to present commercial potential and will also work closely with team members from US, Japan, and EU. The individual is expected to be able to regularly synthesize key analytical outputs in management-ready deliverables to help inform and drive strategic business decisions. In addition to strong therapeutic area knowledge, the individual is expected to have a strong grasp of incorporating insights across market research, competitive intelligence and secondary data analytics to drive the commercial assessment.
How you will contribute:
Ensure that customized, global, strategic forecasts are developed for pipeline assets and BD opportunities with assumptions based on facts and research
Collaborate with team members from commercial/NPP, market research, analytics, competitive intelligence, global pricing and market access, to make sure all relevant market insights inform the forecasts.
Lead the consensus‑building process to gain alignment and/or endorsement for forecast assumptions with the senior stakeholders and Oncology Leadership Team (OLT)
Leverage advanced analytics and integrate data available across multiple sources to enhance our understanding of market impact of the assets being considered
Lead development, training and dissemination of Long Range Forecasting and applicable templates and management summaries for all relevant oncology products to regions and local operating companies of the Oncology Business Unit
Leverage advanced analytics and integrate data available across multiple sources to enhance our understanding of market impact and as a result, Takeda's brand and business strategy.
Lead identification, maintenance, and generation of data references/databases, analogs for continuously improving oncology epidemiology and other forecast inputs, across markets
Create forecasts that are range based, identifying key risk and opportunities of the brands/assets under consideration
Serve as a strategic thought partner to the commercial/NPP teams and other key stakeholders as they work through the strategy to accelerate pipeline assets and evaluate BD opportunities
Manage and supervise a team of Takeda resources and vendors (onshore & offshore team) to deliver on key priorities
Minimum Requirements/Qualifications:
BA/BS degree, Advanced degree preferred.
Minimum of 10 years of relevant experience in forecasting, market research, or business analytics in the biopharmaceutical industry.
Significant experience conducting complex assets valuations in a fast‑paced environment.
Experience with advanced spreadsheets, patient based forecast modeling including dynamic patient models
Experience in business development forecasting, preferred
Experience in oncology, solid tumors, hem tumors or similar specialty areas
Experience with quantitative techniques including smoothing, regression, time series analyses, and simulation. Experience with data analysis and data visualization tools.
Product launch and Global experience. Consulting experience with forecasting, market research or business analysis firm(s)
Broad working knowledge of commonly used biopharmaceutical industry databases
Working knowledge of global access and reimbursement policies, and competitive environment and potential impact on product development and commercialization strategy
Ability to facilitate large meetings and influence senior stakeholders
Ability to work collaboratively in a team‑based environment, including external vendors
Demonstrated excellence in project management and effectively managing multiple projects/priorities.
Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences.
Ability to explain complex concepts to stakeholders in simple language and lead/drive consensus building
Demonstrated analytical skills combined with a client‑service mindset
Demonstrated ability to think strategically, identify key issues and value drivers, and translate strategic insights into an appropriate analytical framework.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as “hybrid” in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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$174.5k-274.2k yearly 5d ago
Hybrid: Global Regulatory Data & Systems Leader
Takeda 4.7
Remote or Boston, MA job
A leading global biopharmaceutical company is seeking a Head of Global Regulatory Information, Data and Systems to develop and implement a comprehensive strategy. This pivotal role involves guiding a team, ensuring regulatory data integrity, and driving system adoption. The ideal candidate has 15+ years of experience in regulatory affairs and data systems, along with a bachelor's degree. The position is hybrid based in Boston, MA, with an attractive salary range between $208,200 and $327,140, plus benefits.
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A global biopharmaceutical leader is seeking an Associate Director, Clinical and Safety Quality Compliance in Cambridge, MA. This hybrid role is pivotal for ensuring the quality of processes and product outputs in compliance with regulations. Candidates should have a BSc in a relevant field, over 7 years of experience in pharma, and strong project management and communication skills. If you're looking to contribute to impactful clinical initiatives, apply now.
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$128k-194k yearly est. 4d ago
Sales Representative - Primary Care - Columbus, Ohio
Shionogi 4.4
Columbus, OH job
The Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Columbus, Ohio territory.
This role requires strong interpersonal skills, a deep understanding of the healthcare market, and the ability to meet and exceed sales targets.
Responsibilities
Effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients
Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations
Build and develop professional relationships with (but not limited to) primary care healthcare professionals, pharmacy staff, within assigned customers and territory
Develop and maintain in-depth knowledge of market, demographic, and managed care information relative to assigned territory
Drive appropriate utilization of approved primary care product(s); the incumbent will work closely with cross-functional partners to generate pull-through within local payers, community HCPs, etc.
Work with District Sales Manager and Regional Sales Director to develop a local strategy and business plan to generate high-performing sales in assigned territory
Capitalize on formulary approvals and other opportunities through effective implementation of targeting plans by using a wide variety of promotional, digital, personnel resources and analytical tools to enhance effectiveness in assigned sales territory, based on local assessment of customer needs.
Leverage expertise and knowledge of primary care marketplace, applicable competitors, industry and cross-functional activities/plans to anticipate and effectively manage business opportunities and challenges
Provide special education to healthcare providers through appropriate programs that fall within Shionogi's guidelines
Provide relevant, thoughtful input to other commercial colleagues (e.g. sales leadership, regional account managers) in regard to strategic and tactical planning for territory, area, and region
Prioritize time and effort to ensure optimal coverage of appropriate physician targets based on opportunity and potential through in-person and virtual discussions
Understand fully the assigned customers' product and business needs and works to meet those needs while adhering to all of Shionogi company ethics and compliance standards
Anticipate potential barriers to achievement of goals and proposes responsible solutions for success
Handle customer objections effectively and exceed customer expectations with the value they bring to physicians. Occasionally will be called on to share your exemplary skills with others in the region in a training capacity
Leverage and embrace emerging technologies to enhance performance, while continuously striving to improve your proficiency
Understand and comply with pharmaceutical industry guidelines and regulations and apply high ethical standard in day-to-day work
Minimum Job Requirements
Qualifications
BS/BA degree required
Minimum 3+ years of experience in pharmaceutical, medical device preferred or related transferrable sales experience
Proven track record of consistent high performance in a sales-focused role or other relevant experience
Proven track record in developing long-standing relationships with customers
Ability to work independently and manage multiple clients
Strong understanding of the primary care market and healthcare industry highly preferred
Demonstrated ethical behavior and compliance with company policies and applicable laws
Knowledge of the medical, healthcare or pharmacy industry and skills in clinical is preferred
Product launch experience is a plus
Knowledge of territory and relationships with key stakeholders already established is a plus
Proficiency in Veeva CRM, Microsoft Teams, Outlook, and calendar-based call planning tools is a plus
Marketing and other commercial experiences with an understanding of financial processes, Market Access, Project Management skills and knowledge of the Regulatory environment within biotech/pharma industry is a plus
Competencies
Possess strong written, organization, administrative and communication skills
Excellent judgment and decision-making skills
Excellent presentation and negotiation skills
Proven ability to receive effective feedback and redirect performance
Results oriented with demonstrated time management skills
Ability to learn, analyze, understand and convey complex information
Ensures compliance with all corporate and industry policies and regulations
Effective prioritization, flexibility and change management in a dynamic environment
Focuses on customer excellence; actively seeks to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions
Develops positive and mutually beneficial relationships internally, to meet and exceed all Company access goals
Proactively takes ownership of situations with a can-do approach
Advanced business analytical skills to identify trends opportunities and threats
Ability to problem solve and determine actions to drive business or overcome challenges
Ability to utilize corporate reporting tools and technology or overcome challenges
Ability to utilize corporate reporting tools and technology
Other Requirements
Ability to comply with any customer credentialing and safety requirements (e.g., up-to-date vaccinations, trainings)
Complete full onboarding curriculum including clinical modules, CRM documentation, and call standards
Pass live call certification and mock objections during training
Attend refresher meetings on product and disease-state updates
Significant field travel (approximately 80%) which can include some overnight and/or weekend work
Valid driver's license with a clean driving record and ability to pass a complete background check
Must have valid licenses and credentialing required to conduct business in assigned territory
Driving in a safe manner to required meetings and appointments
Ability to drive or fly to target accounts, customers, meetings and conventions
Additional Information
The base salary range for this full-time, field-based position is $110,000-$140,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, vehicle allowance, bonus, long-term incentive, or any additional compensation that may be associated with this role.
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling ************ or by sending an email to ***********************.
$110k-140k yearly Auto-Apply 10d ago
Research Scientific Director, Large Molecule AI Development
Takeda Pharmaceuticals 4.7
Remote or Boston, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
**Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects** **Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.**
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
**Key Responsibilities**
**1. AI/ML Application to Pipeline Projects**
+ Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
+ Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
+ Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
+ Act as a hands-on technical leader across multiple programs:
+ Define modeling strategies and architectures
+ Prioritize methods and experiments
+ Review and challenge scientific output for quality and robustness
+ Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
**2. AI/ML Platform Build and Innovation**
+ Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
+ Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
+ Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
+ Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
+ Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
**3. Leadership, Talent, and Culture**
+ Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
+ Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
+ Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
+ Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
**Qualifications**
**Required:**
+ PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
+ Proven track record of leading AI-driven projects in a research pharmaceutical setting.
+ Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
+ Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
+ Significant depth of expertise in at least one relevant area, such as:
+ Machine learning or deep learning
+ Protein or biotherapeutic design
+ Structural modeling or computational biophysics
+ Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
+ Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
**Preferred:**
+ Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
+ Experience building or owning AI/ML platforms or foundational models used across multiple programs
+ Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
**ADDITIONAL INFORMATION**
+ The position will be based in Cambridge, MA.This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Boston, MA
**U.S. Base Salary Range:**
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly 35d ago
2026 U.S Summer Internship Program: Data Scientist Computational Biology Intern
Takeda Pharmaceuticals 4.7
Remote or Cambridge, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
The intern in the Early Clinical Development (ECD) computational biology group at Takeda GI-TAU will implement and test machine learning/deep learning based methods, to integrate and analyze large screening datasets and metadata information to generate actionable insights and interpretation for drug discovery and development questions in Gastrointestinal & Inflammation Therapeutic Area
**How You Will Contribute:**
As a Computational Biology Intern, you will have the opportunity to...
+ Leverage proprietary clinical multi-omics data assets and implement advanced AI/ML approaches.
+ Explore and experiment with innovative strategies for data integration, visualization, and analytical approaches.
+ Engage in the exploration of cutting-edge methodologies aimed at enhancing the precision and depth of analyses.
+ Contribute to the development of advanced techniques within the field of Precision Medicine and Biomarker Discovery.
**Job Requirements:**
+ This position will be Fully Remote out of the Round Lake, Illinois location
+ Must be pursuing a Doctoral Degree in Computational Biology, Bioinformatics, Biostatistics and any other relevant fields.
+ Familiar with machine/deep- learning frameworks/libraries. Experience in testing and implement different deep learning architecture is preferred
+ Strong programming skills in R/Python. Proficiency in Unix/Linux shell, AWS/HPC environment is preferred
+ Working knowledge in molecular biology and clinical metadata
+ Highly motivated with a strong interest in bioinformatics data analysis in drug discovery and development
+ Quick learner, Outstanding oral and written communication skills.
**Internship Eligibility**
+ Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
+ Must be currently enrolled in a degree program graduating December 2026 or later
+ The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
+ The intern must be able to commit to one of these time frames
+ Able to work full time 40 hours a week during internship dates
+ Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
** ** **Program Highlights:**
+ Hands-on experience with real projects and responsibilities
+ Dedicated mentorship program pairing interns with experienced professionals
+ Networking opportunities with industry professionals and fellow interns
+ Internship events focused on professional and skills development
+ Exposure to multiple business areas or departments within a Pharmaceutical Organization
**Applications will be accepted between** **October 31** **st** **- November 16** **th**
**Takeda Compensation and Benefits** **Summary**
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - MA - Cambridge - Binney St
**U.S. Hourly Wage Range:**
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
+ Paid sick time
+ Civic Duty paid time off
+ Participation at company volunteer events
+ Participation at company sponsored special events
+ Access to on-site fitness center (where available)
+ Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - MA - Cambridge - Binney St
**Worker Type**
Employee
**Worker Sub-Type**
Paid Intern (Fixed Term) (Trainee)
**Time Type**
Full time
**Job Exempt**
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Compliance and Continuous Improvement position to support specialty dosage forms and oral solid dosage GMP development activities. This role is primarily responsible for compliance and continuous improvement activities including safety, quality, delivery and continuous improvement within clinical supply Formulation Laboratory and Experimentation (FLEx) Center.
This opening is for the Non-Sterile team in the 880 FLEx Center.
The successful candidate will become an owner and trainer of our manufacturing support processes (safety, compliance, change overs, root cause analysis, continuous improvement program). They will lead the team through continuous improvement projects, along with managing and completing GMP documentation. They will also build a strong team dynamic through continual sharing of knowledge and identification of improvements. They will work closely with peer specialists, formulation scientists, facility engineers and automation engineers to fix processes/system issues and solve root causes. By taking initiative and owning improvement projects to completion, the candidate will help the team progress on our learning journey.
This position is based in Rahway, NJ and is 100% on-site and day-shift.
**Primary Activities**
+ Lead process improvement activities in the oral solid dosage facility
+ Coordinate quick changeover activities on designated equipment trains
+ Define and improve standard work, SOPs, BTD, and overall production flow
+ Support standard Non-Sterile processing as time allows
+ Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOP's, quality procedures, safety, and environmental standards.
+ Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.
+ Develop experience to become a compliance and continuous improvement expert and share knowledge by teaching others.
+ Execution of GMP batch documentation in accordance to local and global operating procedures.
+ Provide support to engineering and formulations staff on Good Manufacturing Practices, facility processes, facility maintenance and batch specific items.
+ Identify and document deviations and atypical events.
+ Lead investigations and document as required.
+ Execute equipment swabbing in support of the cleaning verification program.
+ Support investigations and the implementation of corrective/preventive actions.
+ Support external and internal audits, tours and inspections.
+ Author or assist with the development of SOP's.
+ Complete training and ensure it is up to date.
+ Interface with engineering, safety, quality and maintenance personnel for improvement of our current processes.
+ Lead improvement initiatives.
**Qualifications**
**Required Qualifications:**
+ Bachelor's in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related fields
+ Independent planning, scheduling, and time management skills.
+ Must pass medical screening requirements for production with PAPR (powered air purifying respirators)
+ Ability to move 50 lbs.
+ Ability to troubleshoot and resolve issues utilizing digital skill sets
**Preferred:**
+ Experience in GMP pharmaceutical plant operations
+ Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
+ Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.
+ Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology
+ Experience working with Lean / Six Sigma and continuous improvement projects
+ Experience with: PI Visions, Equipment HMI use, SAP, Calibration/Maintenance Database Systems, Microsoft Office (Word, Excel and Outlook).
+ Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.
\#PSCS
\#eligiblefor ERP
**Required Skills:**
Accountability, Accountability, Analytical Problem Solving, Audit Management, Change Management, Chemical Engineering, Clinical Trials Operations, Equipment Maintenance, Equipment Set Up, GMP Compliance, Good Manufacturing Practices (GMP), Industrial Hygiene, Machinery Operation, Machining, Manufacturing Engineering, Manufacturing Operations, Manufacturing Support, Microsoft Office, Oracle CRM, Pharmaceutical Manufacturing, Pharmaceutical Systems, Process Optimization, Production Planning, Production Scheduling, Project Management {+ 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
$70,500.00 - $110,900.00
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:**
No Travel Required
**Flexible Work Arrangements:**
Not Applicable
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/19/2026
***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:** R378641
$70.5k-110.9k yearly 12d ago
Director, Regulatory Site CMC
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive standardization, scalability, and sustainability.
This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.
We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
How you will contribute:
Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.
Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.
Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.
Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.
Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
Promote sustainable practices and scalability in site-level regulatory operations.
Minimum Requirements/Qualifications:
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
Strong practical experience with global HA requirements, beyond EU/US.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
Analyze issues with attention to detail.
Ability to assess alternative approaches.
Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management.
Understands who is responsible for different decisions and escalates as necessary.
Applies directions taken by the company.
Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
Intentionally promotes an inclusive culture.
Applies given prioritization framework with limited support.
Excellent written and oral communication skills required.
Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.
#LI-Hybrid
#LI-AA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly Auto-Apply 60d+ ago
Specialist, Digital Asset Management
Merck 4.6
Remote or Bismarck, ND job
The US Human Health Global Headquarters (HH GHQ) Asset Management Specialist's scope spans over three primary areas: + Responsible for approving the taxonomy, metadata and classification of the company's digital assets. + Determining the access and usage for these digital assets in their area of responsibility.
+ Acquiring permission to use specific classes of assets that are copyrighted by publishers.
The successful candidate will join the Global Marketing Operations team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The US/GHQ Asset Management Specialist will become the "go to" person for their assigned brands to work in collaboration with Creative Agencies and Job Owners in managing, storing, sharing, and re‑using content and assets in our promotional materials. In addition, a key responsibility is to ensure compliance of copyright agreements with their relevant assets stored in PromoMats. May collaborate with our company's copyright attorneys to resolve copyright concerns.
**Qualifications:**
+ **Education Minimum Requirement:** Bachelor's degree in library, Business and/or Information Science, or 3 years comparable experience in relevant/related field, is required.
+ Candidate must be available to work in the US time zones (EST preferred)
**Required Experience and Skills:**
+ A background in or similar to library science and/or experience with digital asset management, as well as experience with copyright management, is highly desired
+ Knowledge of media usage rights and licensing
+ Proficiency in English language required (written and spoken)
+ Experience working with print and/or multichannel production files
+ Ability to operate independently while managing multiple projects
+ Ability to communicate effectively with, train, and present to multiple stakeholders, including internal marketing teams and external agencies
+ Excellent verbal and written communication
+ Ability to learn new skills quickly
+ Ability to work collaboratively and efficiently within cross‑functional teams
+ Highly detail oriented, exceptional organizational skills, thrive when multitasking, and be able to consistently meet tight deadlines in a timely manner
**Preferred Experience and Skills:**
+ Experience with digital asset management systems
+ Familiarity with Veeva PromoMats
+ Knowledge of the pharmaceutical industry; in particular, familiarity with promotional material review process for the pharmaceutical industry is desired
**Required Skills:**
Communication, Communication, Communications Programs, Content Creation, Copyright Compliance, Customer Journey Mapping, Customer Relationship Management (CRM) Utilization, Data Analysis, Design Thinking, Detail-Oriented, Digital Asset Management (DAM), Digital Assets, Digital Marketing, Enterprise Digital Asset Management, Event Planning, Library Science, Marketing, Marketing Campaign Development, Market Research, Media Relations, Multi-Management, Multitasking, Music Licensing, Oral Communications, Pharmaceutical 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
$77,700.00 - $122,300.00
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:**
Remote
**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.**
**Requisition ID:** R373619
$77.7k-122.3k yearly 11d ago
Senior Director, Global Regulatory Lead - Oncology (Hybrid)
Takeda 4.7
Remote or Boston, MA job
A leading global biopharmaceutical company is seeking a Senior Director, Global Regulatory Lead - Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology programs, setting regulatory direction, and ensuring compliance with FDA submissions. The ideal candidate should possess significant experience in regulatory affairs, strong communication skills, and a proven track record in managing late-stage projects. Takeda offers a hybrid work environment and a competitive salary range between $208,200 and $327,140 annually, along with comprehensive benefits.
#J-18808-Ljbffr
$208.2k-327.1k yearly 4d ago
Research Scientific Director, Large Molecule AI Development
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
Key Responsibilities
1. AI/ML Application to Pipeline Projects
Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
Act as a hands-on technical leader across multiple programs:
Define modeling strategies and architectures
Prioritize methods and experiments
Review and challenge scientific output for quality and robustness
Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
2. AI/ML Platform Build and Innovation
Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
3. Leadership, Talent, and Culture
Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
Qualifications
Required:
PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
Proven track record of leading AI-driven projects in a research pharmaceutical setting.
Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
Significant depth of expertise in at least one relevant area, such as:
Machine learning or deep learning
Protein or biotherapeutic design
Structural modeling or computational biophysics
Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
Preferred:
Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
Experience building or owning AI/ML platforms or foundational models used across multiple programs
Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
ADDITIONAL INFORMATION
The position will be based in Cambridge, MA. This position is currently classified as “hybrid” by Takeda's Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly Auto-Apply 36d ago
Associate Specialist, Packaging Engineer
Merck 4.6
Remote or Rahway, NJ job
The Packaging Commercialization department has an exciting opportunity for an Associate Specialist Packaging Engineer at either the Rahway, NJ or West Point, PA site. This candidate will serve as an individual contributor and foster our department mission to (1) design and develop responsible and accessible commercial packaging solutions with strong science, risk-based thinking, and focus on the customer while (2) striking the balance of being innovative and flexible to meet the evolving pipeline, while also continuously improving and standardizing our packaging solutions.
**Position Description:**
The successful candidate will have the opportunity to focus on package development for a range of traditional pharmaceuticals (oral solid dosage, oral powders, suspensions, sterile injectables, and inhaled formulations) and biopharmaceutical applications (vaccines, monoclonal antibodies, and antibody drug conjugates) as well as provide input to primary packaging for the drug component and secondary packaging of medical device and combination products. Through support of the Packaging Working Groups, the successful candidate will collaborate on diverse, cross-functional teams with peers in drug product formulation and analytical development as well as supply chain and marketing to provide technical guidance during the development of primary, secondary and tertiary packaging for new products and specialty devices.
**Packaging Responsibilities:**
+ Providing input regarding selection of primary packaging material
+ Determination of package images to support commercialization as well as leading the shipping distribution strategy and coordination of shipping distribution studies efforts regarding characterization and qualification testing of robust packaging systems
+ The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of BLA's, NDA's, WMA's, and JNDA's
+ The successful candidate will interface with our internal Global Packaging Technology Operations and Packaging Site Operations teams, as well as external Contract Manufacturing Operations and packaging component suppliers while fulfilling their responsibilities
**Education Minimum Requirement:**
+ The successful candidate will have a completed a B.S. or higher degree in Packaging Engineering, Packaging Science, Biomedical Engineering, Chemical Engineering, Materials Science, or Pharmaceutical Science
**Required Experience and Skills:**
+ Understanding of package development process and engineering principles
+ Demonstrated experience in building collaborative partnerships
+ Excellent verbal and written communication skills
+ Ability to make rapid, disciplined decisions
**Preferred Experience and Skills:**
+ Experience in new product pharmaceutical and/or biopharmaceutical development packaging
+ Strong scientific and risk-based thinking
+ Strong organizational skills and demonstrated ability to deliver on timelines
**Required Skills:**
Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Applied Mathematics, Biopharmaceuticals, Cold Chain Management, Communication, Engineering Standards, Global Health, Healthcare Innovation, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Materials Science, Monoclonal Antibodies, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Science, Packaging Testing, Polyclonal Antibody Production, Quality Leadership, Retail Packaging {+ 3 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
$71,900.00 - $113,200.00
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:**
01/29/2026
***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:** R381110
$71.9k-113.2k yearly 2d ago
Specialist, Digital Asset Management
Merck 4.6
Remote or Carson City, NV job
The US Human Health Global Headquarters (HH GHQ) Asset Management Specialist's scope spans over three primary areas: + Responsible for approving the taxonomy, metadata and classification of the company's digital assets. + Determining the access and usage for these digital assets in their area of responsibility.
+ Acquiring permission to use specific classes of assets that are copyrighted by publishers.
The successful candidate will join the Global Marketing Operations team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The US/GHQ Asset Management Specialist will become the "go to" person for their assigned brands to work in collaboration with Creative Agencies and Job Owners in managing, storing, sharing, and re‑using content and assets in our promotional materials. In addition, a key responsibility is to ensure compliance of copyright agreements with their relevant assets stored in PromoMats. May collaborate with our company's copyright attorneys to resolve copyright concerns.
**Qualifications:**
+ **Education Minimum Requirement:** Bachelor's degree in library, Business and/or Information Science, or 3 years comparable experience in relevant/related field, is required.
+ Candidate must be available to work in the US time zones (EST preferred)
**Required Experience and Skills:**
+ A background in or similar to library science and/or experience with digital asset management, as well as experience with copyright management, is highly desired
+ Knowledge of media usage rights and licensing
+ Proficiency in English language required (written and spoken)
+ Experience working with print and/or multichannel production files
+ Ability to operate independently while managing multiple projects
+ Ability to communicate effectively with, train, and present to multiple stakeholders, including internal marketing teams and external agencies
+ Excellent verbal and written communication
+ Ability to learn new skills quickly
+ Ability to work collaboratively and efficiently within cross‑functional teams
+ Highly detail oriented, exceptional organizational skills, thrive when multitasking, and be able to consistently meet tight deadlines in a timely manner
**Preferred Experience and Skills:**
+ Experience with digital asset management systems
+ Familiarity with Veeva PromoMats
+ Knowledge of the pharmaceutical industry; in particular, familiarity with promotional material review process for the pharmaceutical industry is desired
**Required Skills:**
Communication, Communication, Communications Programs, Content Creation, Copyright Compliance, Customer Journey Mapping, Customer Relationship Management (CRM) Utilization, Data Analysis, Design Thinking, Detail-Oriented, Digital Asset Management (DAM), Digital Assets, Digital Marketing, Enterprise Digital Asset Management, Event Planning, Library Science, Marketing, Marketing Campaign Development, Market Research, Media Relations, Multi-Management, Multitasking, Music Licensing, Oral Communications, Pharmaceutical 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
$77,700.00 - $122,300.00
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:**
Remote
**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.**
**Requisition ID:** R373619
$77.7k-122.3k yearly 11d ago
Research Scientific Director, Large Molecule AI Development
Takeda Pharmaceutical Company Ltd. 4.7
Remote or Boston, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
Key Responsibilities
1. AI/ML Application to Pipeline Projects
* Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
* Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
* Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
* Act as a hands-on technical leader across multiple programs:
* Define modeling strategies and architectures
* Prioritize methods and experiments
* Review and challenge scientific output for quality and robustness
* Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
2. AI/ML Platform Build and Innovation
* Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
* Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
* Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
* Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
* Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
3. Leadership, Talent, and Culture
* Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
* Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
* Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
* Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
Qualifications
Required:
* PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
* Proven track record of leading AI-driven projects in a research pharmaceutical setting.
* Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
* Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
* Significant depth of expertise in at least one relevant area, such as:
* Machine learning or deep learning
* Protein or biotherapeutic design
* Structural modeling or computational biophysics
* Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
* Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
Preferred:
* Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
* Experience building or owning AI/ML platforms or foundational models used across multiple programs
* Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
ADDITIONAL INFORMATION
* The position will be based in Cambridge, MA. This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly 36d ago
Associate Specialist, Commissioning and Qualification Engineer
Merck 4.6
Remote or Nebraska job
The Associate Specialist, Engineering C&Q position will fill a new role at the Elkhorn facility in support of the Commissioning and Qualification team. This position is responsible for developing and executing C&Q protocols across the site. The associate specialist will be responsible for communicating with stakeholders for testing requirements and scheduling. They will work closely with multiple departments on site to ensure equipment and utility systems maintain their validated state and new systems meet GMP requirements. Additionally, the role may take on additional responsibilities to develop skills and meet needs of the Engineering and Maintenance department. This can include troubleshooting equipment, implementing process improvements, investigating site deviations, and updating calibration records.
Key Responsibilities
Develop and execute commissioning, qualification, and validation protocols for equipment utilities and automated systems.
Perform system start-up, troubleshooting and performance verification to ensure readiness for operation.
Prepare and maintain C&Q documentation including protocols, reports, traceability matrices and risk assessments.
Ensure compliance with USDA, 9CFR and other regulatory guidelines.
Support the development and maintenance of validation master plans and user requirement specifications (URS).
Collaborate with Quality Assurance to ensure documentation meets internal and external audit requirements.
Work closely with Engineering, Maintenance, Manufacturing, Automation and Quality teams to ensure seamless project execution.
Identify opportunities to optimize C&Q processes, reduce cycle times and enhance equipment reliability.
Support change control activities and evaluate impact of modifications on validated systems.
Contribute to the development of standard operating procedures (SOPs) for best practices.
Qualifications
Required Qualifications:
Bachelor's in Engineering required (Mechanical, Chemical, Electrical, Biomedical, Biochemistry or related discipline)
Understanding of aseptic processing and equipment cleanability
Strong analytical and problem-solving skills
Ability to write technical reports with key data and conclusions clearly presented
Ability to communicate and present information to groups with varied levels of technical background
Ability to work independently and in cross-functional teams
Physical abilities include:
Use various hand-held measuring devices and manipulate components with dexterity
Sit, stand and walk for up to 8 hours or more per day
Lift and carry up to 25 lbs. on a limited basis
Climb stairs and ladders to access equipment components
Work at a computer for up to 8 hours per day
Tolerate working in unconditioned spaces ( ≥30°C) on a limited basis
Preferred:
Technical understanding of equipment and utility systems such as HVAC, purified water, clean steam, fermentors, bioreactors, autoclaves, and temperature control units including coolers, freezers, and incubators
Hands-on experience in commissioning, qualification or validation within the pharmaceutical, biotech, or related manufacturing industry
Awareness of Good Manufacturing Practices (GMP) in regard to documentation
Aseptic processing experience
Comfortable managing multiple priorities in a fast-paced environment
Other Considerations:
Limited off shift work may be required to meet project, operations, and qualification needs
Travel: Less than 10% travel required
Required Skills:
Accountability, Accountability, Adaptability, Biochemistry, Biopharmaceutical Operations, CAD Proficiency, Change Control Processes, Communication, Construction, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, External Audit, Gauging, GMP Compliance, Good Manufacturing Practices (GMP), High Technology Industry, Immunochemistry, Mechatronics, Process Improvements, Process Optimization, Professional Engineering, Project Management {+ 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
$71,900.00 - $113,200.00
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:
Not Applicable
Shift:
1st - Day
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.
$71.9k-113.2k yearly Auto-Apply 4d ago
Specialist, Digital Asset Management
Merck 4.6
Remote or Concord, NH job
The US Human Health Global Headquarters (HH GHQ) Asset Management Specialist's scope spans over three primary areas: + Responsible for approving the taxonomy, metadata and classification of the company's digital assets. + Determining the access and usage for these digital assets in their area of responsibility.
+ Acquiring permission to use specific classes of assets that are copyrighted by publishers.
The successful candidate will join the Global Marketing Operations team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The US/GHQ Asset Management Specialist will become the "go to" person for their assigned brands to work in collaboration with Creative Agencies and Job Owners in managing, storing, sharing, and re‑using content and assets in our promotional materials. In addition, a key responsibility is to ensure compliance of copyright agreements with their relevant assets stored in PromoMats. May collaborate with our company's copyright attorneys to resolve copyright concerns.
**Qualifications:**
+ **Education Minimum Requirement:** Bachelor's degree in library, Business and/or Information Science, or 3 years comparable experience in relevant/related field, is required.
+ Candidate must be available to work in the US time zones (EST preferred)
**Required Experience and Skills:**
+ A background in or similar to library science and/or experience with digital asset management, as well as experience with copyright management, is highly desired
+ Knowledge of media usage rights and licensing
+ Proficiency in English language required (written and spoken)
+ Experience working with print and/or multichannel production files
+ Ability to operate independently while managing multiple projects
+ Ability to communicate effectively with, train, and present to multiple stakeholders, including internal marketing teams and external agencies
+ Excellent verbal and written communication
+ Ability to learn new skills quickly
+ Ability to work collaboratively and efficiently within cross‑functional teams
+ Highly detail oriented, exceptional organizational skills, thrive when multitasking, and be able to consistently meet tight deadlines in a timely manner
**Preferred Experience and Skills:**
+ Experience with digital asset management systems
+ Familiarity with Veeva PromoMats
+ Knowledge of the pharmaceutical industry; in particular, familiarity with promotional material review process for the pharmaceutical industry is desired
**Required Skills:**
Communication, Communication, Communications Programs, Content Creation, Copyright Compliance, Customer Journey Mapping, Customer Relationship Management (CRM) Utilization, Data Analysis, Design Thinking, Detail-Oriented, Digital Asset Management (DAM), Digital Assets, Digital Marketing, Enterprise Digital Asset Management, Event Planning, Library Science, Marketing, Marketing Campaign Development, Market Research, Media Relations, Multi-Management, Multitasking, Music Licensing, Oral Communications, Pharmaceutical 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
$77,700.00 - $122,300.00
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:**
Remote
**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.**
**Requisition ID:** R373619
$77.7k-122.3k yearly 11d ago
Associate Specialist , Manufacturing Automation
Merck 4.6
Remote or Durham, NC job
The Manufacturing Automation Associate Specialist position shall support a GMP testing laboratory at a manufacturing facility for sterile vaccine products. Responsibilities include supporting computer system validation, implementing process control and data collection, and troubleshooting in compliance with SDLC, cGMP, safety, and environmental regulations. The Manufacturing Automation Associate Specialist must actively support, participate, and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups. This role supports a large spectrum of sophisticated automated systems within Laboratory Operations, providing multiple opportunities to learn new automation technologies and make a positive impact.
**Primary activities include, but are not limited to:**
+ Performs routine assignments in the entry level of a professional role
+ Learns and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations. Review automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.
+ Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of product and on time project execution and system delivery.
+ Provide technical guidance/support including authoring or review of system qualification documents, change control, Quality Notifications (QNs), and other key automation related processes
+ Participates in audits and training programs in the area of responsibility.
+ Participates in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
+ Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through process improvement, future expansion, replacement, or upgrade.
+ Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
+ On-floor support of manufacturing/laboratory activities.
**Education Minimum Requirement:**
+ B.S., B.A., or greater preferably in Engineering, Science, or Information Technology
**Preferred Experience and Skills:**
+ Experience in PLCs, SCADA, laboratory equipment, and/or PI.
**Required Skills:**
Accountability, Audit Management, Business Process Improvements, Collection Processes, Communication, Corrective Action Management, Data Collection Methods, Data Management, Environmental Health And Safety, Environmental Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Automation, Leadership, Manufacturing, Problem Management, Quality Management, Real-Time Programming, SCADA Control Systems, Software Development Life Cycle (SDLC), System Validation, 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
$71,900.00 - $113,200.00
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:**
No Travel Required
**Flexible Work Arrangements:**
Hybrid
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
01/19/2026
***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:** R380504
$71.9k-113.2k yearly 5d ago
Specialist, Digital Asset Management
Merck 4.6
Remote or Rahway, NJ job
The US Human Health Global Headquarters (HH GHQ) Asset Management Specialist's scope spans over three primary areas:
Responsible for approving the taxonomy, metadata and classification of the company's digital assets.
Determining the access and usage for these digital assets in their area of responsibility.
Acquiring permission to use specific classes of assets that are copyrighted by publishers.
The successful candidate will join the Global Marketing Operations team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The US/GHQ Asset Management Specialist will become the “go to” person for their assigned brands to work in collaboration with Creative Agencies and Job Owners in managing, storing, sharing, and re‑using content and assets in our promotional materials. In addition, a key responsibility is to ensure compliance of copyright agreements with their relevant assets stored in PromoMats. May collaborate with our company's copyright attorneys to resolve copyright concerns.
Qualifications:
Education Minimum Requirement: Bachelor's degree in library, Business and/or Information Science, or 3 years comparable experience in relevant/related field, is required.
Candidate must be available to work in the US time zones (EST preferred)
Required Experience and Skills:
A background in or similar to library science and/or experience with digital asset management, as well as experience with copyright management, is highly desired
Knowledge of media usage rights and licensing
Proficiency in English language required (written and spoken)
Experience working with print and/or multichannel production files
Ability to operate independently while managing multiple projects
Ability to communicate effectively with, train, and present to multiple stakeholders, including internal marketing teams and external agencies
Excellent verbal and written communication
Ability to learn new skills quickly
Ability to work collaboratively and efficiently within cross‑functional teams
Highly detail oriented, exceptional organizational skills, thrive when multitasking, and be able to consistently meet tight deadlines in a timely manner
Preferred Experience and Skills:
Experience with digital asset management systems
Familiarity with Veeva PromoMats
Knowledge of the pharmaceutical industry; in particular, familiarity with promotional material review process for the pharmaceutical industry is desired
Required Skills:
Communication, Communication, Communications Programs, Content Creation, Copyright Compliance, Customer Journey Mapping, Customer Relationship Management (CRM) Utilization, Data Analysis, Design Thinking, Detail-Oriented, Digital Asset Management (DAM), Digital Assets, Digital Marketing, Enterprise Digital Asset Management, Event Planning, Library Science, Marketing, Marketing Campaign Development, Market Research, Media Relations, Multi-Management, Multitasking, Music Licensing, Oral Communications, Pharmaceutical 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
$77,700.00 - $122,300.00
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:
Remote
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.
$77.7k-122.3k yearly Auto-Apply 12d ago
Associate Specialist, Commissioning and Qualification Engineer
Merck 4.6
Remote or Omaha, NE job
The Associate Specialist, Engineering C&Q position will fill a new role at the Elkhorn facility in support of the Commissioning and Qualification team. This position is responsible for developing and executing C&Q protocols across the site. The associate specialist will be responsible for communicating with stakeholders for testing requirements and scheduling. They will work closely with multiple departments on site to ensure equipment and utility systems maintain their validated state and new systems meet GMP requirements. Additionally, the role may take on additional responsibilities to develop skills and meet needs of the Engineering and Maintenance department. This can include troubleshooting equipment, implementing process improvements, investigating site deviations, and updating calibration records.
**Key Responsibilities**
+ Develop and execute commissioning, qualification, and validation protocols for equipment utilities and automated systems.
+ Perform system start-up, troubleshooting and performance verification to ensure readiness for operation.
+ Prepare and maintain C&Q documentation including protocols, reports, traceability matrices and risk assessments.
+ Ensure compliance with USDA, 9CFR and other regulatory guidelines.
+ Support the development and maintenance of validation master plans and user requirement specifications (URS).
+ Collaborate with Quality Assurance to ensure documentation meets internal and external audit requirements.
+ Work closely with Engineering, Maintenance, Manufacturing, Automation and Quality teams to ensure seamless project execution.
+ Identify opportunities to optimize C&Q processes, reduce cycle times and enhance equipment reliability.
+ Support change control activities and evaluate impact of modifications on validated systems.
+ Contribute to the development of standard operating procedures (SOPs) for best practices.
**Qualifications**
**Required Qualifications:**
+ Bachelor's in Engineering required (Mechanical, Chemical, Electrical, Biomedical, Biochemistry or related discipline)
+ Understanding of aseptic processing and equipment cleanability
+ Strong analytical and problem-solving skills
+ Ability to write technical reports with key data and conclusions clearly presented
+ Ability to communicate and present information to groups with varied levels of technical background
+ Ability to work independently and in cross-functional teams
**Physical abilities include:**
+ Use various hand-held measuring devices and manipulate components with dexterity
+ Sit, stand and walk for up to 8 hours or more per day
+ Lift and carry up to 25 lbs. on a limited basis
+ Climb stairs and ladders to access equipment components
+ Work at a computer for up to 8 hours per day
+ Tolerate working in unconditioned spaces ( ≥30°C) on a limited basis
**Preferred:**
+ Technical understanding of equipment and utility systems such as HVAC, purified water, clean steam, fermentors, bioreactors, autoclaves, and temperature control units including coolers, freezers, and incubators
+ Hands-on experience in commissioning, qualification or validation within the pharmaceutical, biotech, or related manufacturing industry
+ Awareness of Good Manufacturing Practices (GMP) in regard to documentation
+ Aseptic processing experience
+ Comfortable managing multiple priorities in a fast-paced environment
**Other Considerations:**
Limited off shift work may be required to meet project, operations, and qualification needs
Travel: Less than 10% travel required
**Required Skills:**
Accountability, Accountability, Adaptability, Biochemistry, Biopharmaceutical Operations, CAD Proficiency, Change Control Processes, Communication, Construction, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, External Audit, Gauging, GMP Compliance, Good Manufacturing Practices (GMP), High Technology Industry, Immunochemistry, Mechatronics, Process Improvements, Process Optimization, Professional Engineering, Project Management {+ 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
$71,900.00 - $113,200.00
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:**
Not Applicable
**Shift:**
1st - Day
**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.**
**Requisition ID:** R381424
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Horizon Pharma USA, Inc. may also be known as or be related to Horizon Pharma USA, Horizon Pharma USA Inc, Horizon Pharma USA Inc. and Horizon Pharma USA, Inc.