Supply Chain Manager jobs at Bristol-Myers Squibb

This role will lead and drive the Sales and Operations Planning (S&OP) process for Casgevy, a commercially launched product within Vertex's Cell and Gene Therapy portfolio. This is a critical role within the Vertex Supply Chain, that includes the ability to perform complex modeling, utilizing assumptions, demand and capacity to meet both short- and long-term requirements. The Associate Director will be responsible for working with the commercial team to align assumptions and the demand plan, External Manufacturing to work with CDMO's to align capacity assumptions, Finance, Materials, Quality Control and Regulatory that will culminate in the monthly S&OP process. This role will be responsible for establishing and communicating key assumptions, as well as scenario management which often requires modeling outside of the current system to understand capacity / demand alignment and financial impact. Additionally, the AD will oversee several Key Performance Indicators (KPI's) that are managed within the S&OP process and identifying areas for improvement. The Associate Director will use the dynamic capacity model to recommend scheduling strategies, future capacity needs, and capacity utilization strategies based on unexpected events (i.e. patient withdrawals, suite downtime, etc.). The selected individual will build and lead the monthly S&OP meetings and play an integral role in the development and communication of Vertex's Cell and Gene Therapy assets. As the Cell and Gene Therapy Supply Chain matures at Vertex, this role will be responsible for the implementation of a new planning tool that will systematize the planning process. This involves working cross-functionality with finance, external manufacturing and materials management to identify and document requirements, and working with the integration team to implement. The output of this implementation will be an integrated plan that takes demand and capacity to create an output that will be implemented across CDMO's, materials suppliers, testing sites and for financial purposes. Key Duties and Responsibilities: * Lead development of a commercial capacity model across multiple CMOs. * Maintain, utilize, and improve upon a capacity model that is dynamic, allowing for long range planning, situational planning, and analysis of unexpected events. * Ability to perform detailed modeling (Excel), analyze and present data, and systematize as needed * Excellent knowledge of Supply Chain systems * Ability to lead teams, both directly (dotted line) and cross-functionally * Integrate the capacity model into the manufacturing strategy, allowing for scenario planning and scheduling. * Integrate the capacity model into the commercial strategy, allowing for direct connection with demand forecasting and scheduling tools. * Integrate the capacity model into the COGS model, allowing for direct impact assessment of COGS due to any capacity assumption changes. * Lead S&OP meetings to align demand, capacity and assumptions. * Excellent interpersonal, verbal and written communication skills * Anticipate future industry trends and keep abreast with a strong foundation of knowledge of manufacturing, development, and supply Knowledge and Skills: * Bachelor's degree in a scientific or business discipline preferred, or equivalent years of relevant experience * 8+ years of experience in Manufacturing and Supply Chain Management; experience in Cell and Gene Therapy is a plus. * Proven ability to manage multiple projects with high degree of effectiveness * Possesses a distinguished record of delivering on critical project goals and moving projects forward * Exhibits robust knowledge across supply chain disciplines * Demonstrates strong aptitude for managing and motivating others and building team unity * Proven ability to communicate clearly and concisely (written/oral) with all levels of the company * Good understanding of the cell and gene therapy and biotech industry and market * High level understanding of GMP processes and regulatory requirements * Ability to effectively plan, prioritize, execute, follow up and anticipate challenges * Results orientated with strong sense of urgency to mitigate risk and close issues * Knowledge of systems with skills and proficiency to download and analyze data * Ability to communicate complex problems and necessary decision points both visually and verbally Education and Experience: * Bachelor's degree in a scientific or business discipline * Typically requires 8 years of experience or the equivalent combination of education and experience Pay Range: $149,300 - $224,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Job DescriptionDescription: Experienced and professional Manger of Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking's San Diego site. The Manager of Clinical Supply Chain will report to the Director of Clinical Supply Chain. The position is highly cross-functional and will work with Quality Control, Quality Assurance, CMC, development team, regulatory, and external vendors. The Sr Manager of Clinical Supply Chain will represent Supply Chain function for Viking to define and operationalize Supply Chain system, to support clinical material manufacturing globally, and to determine distribution strategy for the lifecycle of products from pre-IND through post launch. Essential Duties And Responsibilities The main responsibilities of this role include but are not limited to the following: • With minimal supervision, manage and support investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management • Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial • Manage of packaging and labeling/distribution vendors, including relationship management • Manage preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating the origination, proofing, and translation of clinical study labels and generation • Proactively identifying potential issues and developing mitigating actions • Interpret clinical synopses and protocols to create clinical IMP demand forecasts • Attend clinical study and cross functional meetings as needed • Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain • Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction • Support drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations) • Support temperature excursion processes are executed as required • Support IRT System development. Lead development of user requirement specifications and management module(s) as applicable • Various other duties as assigned Requirements: • Bachelor's degree in Chemistry, Pharmacy or other relevant discipline. • 6+ years of industry experience in Supply Chain Operations. • Significant experience with global shipping and logistics of materials. • Experience working in an FDA-regulated environment is required. • Experience with establishment and maintenance of GMP quality-controlled storage • Direct experience with importing/exporting documentation (permits, licenses, declaration letters) for global distribution of live virus banks, cell banks, and raw materials. • Direct experience with 3rd party vendors for shipping/logistics service • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for the pharmaceutical industry. • Experience in reviewing and authoring SOPs related to CMC Clinical supply chain. • Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries. • Experience with Inventory Management Systems is a plus. • Technical working knowledge and/or experience in product packaging or design a plus. • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities. • Strong computer skills with Microsoft Office and the ability to quickly learn new applications. • Team player with demonstrated strong communication skills, interpersonal skills, and ability to build effective working relationships throughout all levels of the organization. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Summary:** This is an exciting opportunity for a seasoned supply chain professional to take a strategic leadership role in a dynamic pharmaceutical environment. As the Supply Chain Planning Manager, you will be at the forefront of ensuring product availability by aligning market demand with manufacturing capabilities across internal and external sites. Youll lead a team of planners, collaborate cross-functionally, and drive continuous improvement in supply performance. This role offers significant visibility and impact, with opportunities to influence executive-level planning, manage high-priority projects, and contribute to the successful launch and lifecycle management of products. Ideal for someone looking to grow their career in a fast-paced, mission-driven organization. **Duties and Responsibilities:** + Direct activities of staff and manage projects with other cross-functional teams at site + Oversee weekly review meeting with manufacturing site. Provide content for monthly Executive S&OP + Provide POs and forecasts to contract manufacturers ensuring adequate supply + Ensure material availability to meet Finished Goods Supply plan + Track Demand Vs Commit Vs Supply on ongoing basis + Work with cross-functional team to improve the gap between demand vs commit vs supply + Material planning using various electronic platforms, including SAP, MRP, APO + Coordinate with Site CFT for release of materials as well as Finished products + Track nonmoving, slow-moving inventory; coordinate with corporate team for disposition approvals + Work with DEA team for quota applications of all list chemicals and controlled substances + Work in Trackwise for generating/approving QMS records as required + Issue process orders for manufacturing, in-house packing, and CMO packing + Partner with marketing and finance teams on activities like sales forecast budgets + Approve and/or create order quantities or purchase order push outs; reflow production schedules based on priority + Work effectively with site CFT and drive business priorities + Timely escalation to management on critical supply aspects + Support the monthly Sales and Operations Planning + Manage projects, including new product launches and life cycle changes, across functions and within supply chain to ensure timelines are realized + Other duties as assigned by management + KPIs include: improve sufficiency, reduce backorder, improve demand vs supply, reduce failure to supply, reduce SLOB (API/RM) **Qualifications:** + Bachelors degree in Business Management, Supply Chain Management, or Operations Management; Masters preferred + 8+ years experience in a supply chain role, preferably in the pharmaceutical industry or 6 + years with Masters. + 2+ years leading a team + Familiarity with production planning, supply chain experience, and an understanding of generic pharmaceutical trade sales models preferred + Proficient in Excel and other analysis/reporting tools; working knowledge of SAP + Excellent analytical, mathematical, and verbal/written communication skills + Strong understanding of manufacturing processes **Direct Reports:** + 2 Supply Planners _The presently-anticipated base compensation pay range for this position is $84,500 to $105,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

We are seeking a strategic and hands-on Director, HR Business Partner to support one or more sub-functions within the Biopharmaceutical Sciences & Manufacturing Organization (BSMO) during a pivotal phase of growth and innovation. In this role, you will be a visible HR leader within the sub-function, serving as a trusted advisor to senior leaders and their teams. You will shape the people and organization strategy, enable business outcomes, and foster a high-performance, agile culture across a regulated manufacturing and technical development environment. This is a senior individual contributor role that leads through influence-orchestrating outcomes across a matrix, aligning cross-functional stakeholders, and leveraging specialist HR centers of excellence to deliver integrated solutions. Key Duties and Responsibilities: Strategic HR & Business Partnership * Serve as the primary HR partner to one or more senior leaders for assigned BSMO sub-function(s); translate business strategy into a prioritized, integrated people and organization plan. * Influence executive decision-making through clear options, risk/benefit tradeoffs, and data-backed recommendations that connect talent levers to operational, quality, and cost outcomes. Organization Design, Capability, & Operating Model * Lead org design and evolution for growth, complexity, and scale (e.g., standing up new capabilities, optimizing spans/layers, clarifying interfaces and governance). * Define and build critical capabilities, partnering with leaders to close skill gaps via targeted build/buy/borrow strategies. Strategic Workforce Planning (SWP) & Succession * Own the sub-function's multi-year workforce plan aligned to long-range strategy, capacity, and budget-headcount, skills, pipeline, and location strategy. Ensure the plan aligns to the broader enterprise level plans for BSMO and Vertex. * Drive succession readiness for pivotal roles; develop diverse slates and growth plans that ensure continuity for GMP operations and technical/scientific leadership. Talent, Performance, & Leadership Effectiveness * Elevate leadership performance at the senior levels and with their teams: build management routines, coach through inflection points, and raise the performance bar with clarity and fairness. * Partner with Talent Management to deploy targeted programs (e.g., high-potential acceleration, career pathways, technical leadership tracks). Culture, Engagement, & Change Leadership * Diagnose and shift culture in alignment with BSMO strategic culture roadmap and steward change for network expansions, tech transfers, or portfolio pivots. * Design and execute change plans (case for change, stakeholder maps, comms, adoption metrics) across multi-site and cross-functional contexts. People Analytics & Insights * Leverage data to illuminate trends (e.g., attrition risk in critical skills, shift staffing dynamics, succession health). * Convert insights into simple, compelling narratives that build alignment and prompt action; measure impact and iterate. HR Operating Model & Governance * Orchestrate with Total Rewards, Talent Acquisition, People Experience, Talent Management, and Strategic Analytics to deliver integrated solutions at pace. * Ensure flawless execution of core cycles (performance, calibration, compensation planning) with equity, transparency, and business relevance. Knowledge and Skills: * Experience developing and implementing HR strategies * Expert-level experience developing strategic workforce plans, from conception to implementation * Highly experienced in talent management, succession planning, and career growth and development * Strong experience managing and/or leading culture and change management or organizational effectiveness initiatives * Experience and expert understanding of management development, employee relations, data and analytics, diversity and inclusion Education and Experience: * Bachelor's degree or equivalent in management, human resources, business, or related discipline. * 10+ years of progressive HR experience, including HRBP leadership in a regulated manufacturing environment (biotech/pharma strongly preferred). * Demonstrated impact partnering with senior-level clients in complex, matrixed organizations; proven ability to lead without direct authority. * Expertise in organization design, strategic workforce planning, succession, and talent management, with experience in technical/manufacturing populations preferred. * Fluency with people data and financial/budget trade-offs; able to link talent decisions to operational, quality, safety, and cost outcomes. * Depth in change leadership and organizational effectiveness with measurable results in high-stakes, time-bound transformations. * Experience across GMP manufacturing and technical development (e.g., MS&T, process development, QA/QC, supply/tech transfer) and partnering with site and network leaders. * Track record building capabilities at scale (e.g., new modalities, network expansion, digital/automation in labs/plants). * Exposure to global or multi-site contexts; comfort operating across time zones and cross-functional leadership teams. #LI-EE1 #LI-Hybrid Pay Range: $185,600 - $278,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Manager, Clinical Supply and Logistics will be the liaison between the Clinical Research Operations team and the Technical Operations team to facilitate cross functional collaboration for proactive problem solving and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the strategic planning and execution of new clinical trial supply chains on time and within budget and is tasked with supporting an integrated operating model with close collaboration with cross functional stakeholders. Responsibilities • Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations. • Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics. • Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans. • Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time. • Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management. • Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply. • Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members. • Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members. • Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members. • Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics. • Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status. • Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations. • Other tasks as requested by managers. Qualifications • Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline. • 5+ years of related experience supporting clinical trial teams. • Experience managing clinical trial vendors. • A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required • Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $95,000-180,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Manager, Clinical Supply and Logistics will be the liaison between the Clinical Research Operations team and the Technical Operations team to facilitate cross functional collaboration for proactive problem solving and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the strategic planning and execution of new clinical trial supply chains on time and within budget and is tasked with supporting an integrated operating model with close collaboration with cross functional stakeholders. **Responsibilities** - Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations. - Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics. - Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans. - Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time. - Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management. - Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply. - Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members. - Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members. - Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members. - Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics. - Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status. - Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations. - Other tasks as requested by managers. **Qualifications** - Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline. - 5+ years of related experience supporting clinical trial teams. - Experience managing clinical trial vendors. - A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required -Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills -Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion. _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-HYBRID _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $95,000-180,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-IL-Chicago_ **Title** _Manager, Clinical Supply & Logistics_ **ID** _2025-2272_ **Category** _Clinical Development_ **Type** _Full-Time_

Job Description Qualifications Purpose & Scope: The Clinical Supply Chain Operations Manager provides leadership, direction, and mentorship to the Clinical Supply Chain team, fostering a high-performance culture grounded in operational excellence, accountability, and continuous learning. This role oversees the operational and strategic management of supply chain functions. The manager ensures the seamless flow of materials, compliance with regulatory standards, and alignment with organizational goals to support clinical excellence and patient care. Education: Bachelor's degree in supply chain, Finance, Business, or a related field. Experience: Three (3) years of experience in Supply Chain Management is required. Certification/Licensure: Certified Materials & Resource Professional (CMRP) preferred. Other Qualifications Advanced proficiency in MS Excel and data analytics. Working knowledge of Workday and experience with EPIC Cogito, including Reporting Workbench and SlicerDicer. Proficient in PowerPoint, Word, and Graphic Design. Familiar with Lean Six Sigma principles and continuous improvement methodologies. The ability to learn and adapt quickly to healthcare-specific challenges, with a solid understanding of medical terminology. Strong analytical and problem-solving skills; independently analyzes data, provides actionable insights, and collaborates with leadership and cross-functional teams. Proven success in leading mid- to large-scale projects and process improvement initiatives across cross-functional teams. Exceptional communication, organizational, and coaching skills. Skilled in presenting complex information to all levels of leadership. Knowledge of surgical supplies, instruments, and procedures. Strong organizational, analytical, and problem-solving skills. Familiarity with ERP or inventory systems (e.g., Workday, Lawson, Cerner, Pyxis). Ability to work in a fast-paced environment with attention to detail. Excellent communication and teamwork skills.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Step into the role of Global Supply Chain Customs & Trade Manager and lead the charge in ensuring compliant, efficient cross-border operations across the U.S. and Canada. You'll play a critical part in mitigating risk, optimizing costs, and aligning regional activities with global customs strategies-keeping trade flowing seamlessly and securely. Your Key Responsibilities: * Lead implementation of customs compliance programs in the U.S. and Canada, aligned with global policies * Serve as internal consultant on customs and regulatory matters for North American business units and corporate functions * Oversee customs audits and focused assessments, ensuring organizational readiness and alignment * Maintain and update the North America Customs Manual and ensure compliance with security programs * Drive improvements in customs-related master data in SAP and advise on tariff classification, country of origin, and labeling requirements * Identify and implement duty savings and trade optimization programs and manage the Duty Drawback program and related third-party engagements We Bring: * A dynamic, global environment with exposure to cutting-edge manufacturing and supply chain technologies * A space to grow by encouraging and supporting curiosity and an open mindset * Barrier-free communities within our organization where every employee is equally valued and respected - regardless of their background, beliefs, or identity * An eagerness to be one team and learn from each other to bring progress to life and create a better future * A vibrant, creative atmosphere where innovation is celebrated * Empowerment to make meaningful contributions while upholding ethical standards You Bring: * Minimum of 5 years of experience managing U.S. and Canadian import/export compliance in a multinational environment * Experience managing U.S. Customs Reconciliation Programs, including oversight of post-entry adjustments, compliance reviews, and coordination with customs brokers and internal stakeholders * Familiarity with C-TPAT and other security programs * Basic understanding of chemistry and product composition * Experience with Harmonized Tariff Schedule and classification of products * Bachelor's degree in business, International Trade, or related field required The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $128,000-$150,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. The application process Interested in this position? Please apply online by uploading your resume in English via our career portal by November 21, 2025. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: * preventing blindness through vision-saving medications * delivering best-in-class proprietary pharmaceutical technologies * transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. The Director of Commercial Supply Chain will be responsible for developing and executing strategies for global supply of DURAVYU through all stages of commercial manufacturing including packaging, labeling, and distribution. The role will drive process improvements, enhance supply planning capabilities, and ensure compliance with global regulatory requirements while managing operations within a GxP environment. This position will be primarily based in Northbridge, MA, with Materials Management & Supply Chain responsibilities across both Watertown and Northbridge facilities. This position will report to the Sr. Director, Manufacturing & Supply Chain Operations. We offer a hybrid work schedule. Excellent Compensation Package, including Equity and Comprehensive Benefits upon hire. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities * Ensures safety, quality, and compliance in our cGMP Materials Management / Logistics operations. * Establishes and executes plans that enable operational and strategic initiatives. * Leads and coordinates resources to ensure product quality standards and supply plans are met within planned budget. * Develops and implements metrics to track and lead successful, timely accomplishment of assigned goals, objectives and projects. * Provides organizational leadership of the Commercial Supply Chain team. Lead all aspects of team talent management, including performance, career development, and succession planning. * Develops short/long term strategies, goals, objectives, and associated budgets required to ensure appropriate manufacturing operations and site deliverables. * Delivers strong results consistent with compliance requirements and values. * Prepares and maintains department budget and workforce model. * Champions innovation and continuous improvement via the introduction of process improvements, automation, and new technologies. * Responsible for leading Materials Management and Logistics-related investigations, ensuring consistency and compliance with external regulatory requirements. * Responsible for development and implementation of commercial supply plans. * Responsible for Materials Management and GMP Warehouse Logistics functions. * Plans, establishes, manages and monitors forecast activities related to commercial clinical supply. * Manages vendors to ensure timely delivery of commercial product that meets Regulatory and budgetary requirements. Ensures that key project milestones are met. * Works with other internal functions and external partners to manage complex projects, negotiate and communicate supply plan timelines to internal and external customers and partners. * Works with internal stakeholders to establish and ensure that regulatory, clinical, quality and CMC plans and interdependencies are thoughtfully laid out to ensure a unified approach for assurance of supply chain activities. * Maintains and ensures compliance to all SOPs. Identifies gaps and makes appropriate mitigation recommendations to ensure global compliance. Develops new functional SOPs, as necessary, and provides training to staff. * Maintains a continuous improvement mentality to enhance commercial supply chain processes. * Recruits, retains and develops high-performing and diverse teams * Builds empowered teams that put patients and EyePoint first * Serves as a role model and coaches and develops team towards their fullest potential. * Represents department to regulatory authorities as necessary * Fosters and maintains relationships with key site, company, and network partners. Qualifications Primary skills and knowledge required include, but are not limited to the following: * Experience in small molecule drug product and/or combination drug-device commercial supply chain. * Advanced knowledge of cGMP's, associated CMC quality systems and regulatory considerations in a pharmaceutical setting. * Demonstrated leadership, collaboration, and team building skills; ability to connect with all levels of the organization * Deep knowledge of the drug discovery, development and commercialization processes * Proven ability to manage multiple high-priority projects with high degree of effectiveness. * Ability to navigate and be successful in a fast-paced, highly matrixed work environment. * Broad experience navigating cross-functional teams through critical scientific, regulatory and general development and global commercialization issues. * Strong collaboration and negotiation skills, analytical and problem-solving skills. * Strong written and verbal communication skills. Working knowledge of project controls in cost and financial assessments is desirable. * Ability to balance multiple priorities and work against tight timelines as well as continually evaluate, measure, analyze and report on collaboration success, potential risks or new opportunities. * Diverse, hands-on operations experience. * Proven managerial experience and track record of compliance in a highly regulated GMP environment. * Understanding of regulatory requirements for global commercial supply distribution and labeling. * Understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials. Level of Education Required: * Bachelor's degree in supply chain management, manufacturing, life sciences or relevant related field. Number of Years of Experience in the Function and in the Industry: * Master's degree & 7+ years of experience in a pharmaceutical Supply Chain / Operations field OR * Bachelor's degree & 9+ years of experience in a pharmaceutical Supply Chain / Operations field AND * Minimum of 5 years of managerial experience directly leading people in a multi-tiered (GMP) organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources. * Prior experience developing and setting up a commercial supply chain infrastructure to support product launch. Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Hybrid Min USD $193,640.00/Yr. Max USD $244,463.00/Yr.

Director of Supply Chain Who we are… We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living. Who you are… You excel at building strong, collaborative relationships across all levels of the organization and with external partners. Your talent lies in connecting teams, suppliers, and stakeholders to foster trust, open communication, and mutual understanding. You are driven by a commitment to teamwork and continuous improvement, always seeking to unite diverse perspectives for innovative solutions. Words that describe you include connector, empathetic, influential, and collaborative. What you can expect to work on… The Director of Supply Chain oversees all facets of supply chain management in a manner consistent with company and cost objectives including the deployment of common systems, improved processes, and advanced technology to drive continuous improvement and supply chain distribution optimization Manage processes to continuously improve quality performance and customer satisfaction Create and execute plans to boost efficiency, productivity, and quality in line with goals Track industry trends and advances to stay competitive Oversee budgets for financial discipline and targets Build strong relationships with stakeholders Manage and improve supply chain procedures for purchasing, planning, inventory, and shipping Lead and develop a diverse supply chain team Drive process improvements with new technologies to increase output and reduce waste Ensure quality standards meet customer needs Stay compliant with NRC, cGMP, and certifications Streamline storage and distribution for compliance and OTIF delivery Continuously enhance quality and customer satisfaction What you need to succeed… Bachelor's degree in Business Management, Warehousing/Supply Chain/Logistics, or related field 10+ years of progressively increasing managerial experience in a production environment 5+ years of supply chain experience in the pharmaceutical industry 8+ years of experience in a leadership role, developing, and managing a group or department 8+ years of experience coaching, mentoring, and providing day-to-day supervision to a staff of 10 or more Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal Understands how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state Understands your own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two Possesses a strong interest and ability to lead and develop staff and teams Demonstrates motivational and leadership abilities, effective communication, proactive problem-solving, analytical thinking, and negotiation skills. Develops and maintains good relationships, gains the confidence of others, and works effectively in a multidisciplinary matrix environment Shows strong proficiency in data analysis, tracking metrics, and use of data analysis tools Great to have… Advanced degree in Supply Chain Management practice or MBA Hands-on experience utilizing lean principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S) 8+ years of supply chain experience in the pharmaceutical industry ERP System rollout experience APICS Certification Other things to note… Full-time position The company's standard operating hours are Monday thru Friday 6:00 a.m. - 6:00 p.m. with production related activities requiring 24/7/365 shifts This position will have regular working hours Monday-Friday with an expectation of adjusting to working outside of the standard operating hours as assigned Niowave has multiple locations within the Lansing area and travel between locations is expected in the role Additional travel related to supply acquisition, vendor management, etc. may be required Please provide a cover letter specifically describing your expertise and leadership experience.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Your mission Manage end-to-end supply chains for finished pharmaceutical products (FDF) Help establish new supply chains and optimize existing ones Ensure compliance with pharmaceutical, regulatory, and commercial requirements Prioritize quality and supply chain security Collaborate and negotiate with international customers, suppliers, and partners Travel nationally and internationally to support projects and maintain relationships Coordinate closely with internal departments: Quality Management, Regulatory Affairs, Business Development, Product Development, and IP Management Your profile Degree in pharmacy, economics, natural sciences, or equivalent professional training Initial experience in pharma-related areas (e.g., quality, regulatory affairs, product development) is a plus Skilled in negotiation, even in challenging project environments Business fluent in English (written and spoken) Enjoy working in cross-functional, interdisciplinary teams Proficient in ERP systems and MS Office About us Where people make the difference Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference. We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.

The Director of AI and Robotics Transformation will lead the design and execution of AI, predictive science and robotics initiatives within Manufacturing Sciences. This pivotal role will advance the "art of the possible" by collaborating with expert functions (e.g. DSM, R&D IT) and transformation teams (e.g. Modelling, AI, Simulations & Twins, MAST, RACT) to deliver high-impact, value-driven solutions that transform our ways of working in a coordinated and scalable manner. The successful candidate will drive multi-year AI and Robotics transformation roadmaps, prioritize and deliver Robotics, AI and predictive tools aligned with business objectives. They will rapidly evaluate emerging technologies, scale successful pilots, and ensure projects remain on track and within budget. In addition, this role will spearhead function-wide change management for AI and Robotics, fostering a culture of continuous learning, promoting AI literacy, and clearly communicating the vision and benefits of AI and Robotics across the organization. As Manufacturing Science's representative on cross-functional transformation teams (e.g. MAST, RACT), this role will ensure functional priorities are incorporated into broader initiatives while providing visibility into key functional projects. This position also offers the opportunity to lead cross-functional projects when required, driving collaboration and delivering shared organizational objectives. Ideal candidates will be strategic leaders with a proven track record in implementing AI, predictive science and Robotics within the Manufacturing Sciences or related functional area. They will be passionate about digital transformation and skilled at guiding cross-functional teams to achieve measurable outcomes and meaningful change. Key Responsibilities Develop, drive, and iteratively refine a functional specific AI and predictive science strategy aligned with business objectives and emerging trends. Develop, drive, and iteratively refine a functional specific Robotics strategy aligned with business objectives, emerging trends and Manufacturing of the Future. Define and maintain the functional roadmaps, ensuring prioritization and alignment with departmental transformation goals. · Collaborate with expert functions (e.g. DSM) to manage end-to-end delivery of AI and predictive science projects, ensuring stakeholder engagement from requirements definition through PoC, pilot, and full production deployment. Lead and serve as a key contributor to functional matrix teams, fostering close collaboration with expert functions to deliver functional projects. Accelerate adoption by creating training programs, communication plans, and KPIs to measure impact and success. Partner with leadership to assess and adapt functional capabilities (talent, technology, capacity) to accelerate and scale delivery of the multi-year roadmap. Represent Manufacturing Sciences in transformation teams (e.g., MAST, RACT), ensuring functional requirements are met by actively influencing cross-functional decisions. Proactively share functional plans and progress with the wider department. Lead major cross-functional digital transformation projects when required. Qualifications & Experience Strong leadership and strategic thinking skills, with a proven ability to drive organizational change. Deep understanding of Biopharmaceutical Development scientific processes and associated challenges. Demonstrated experience managing complex, multi-stakeholder projects and leading cross-functional teams. Substantial exposure to AI technologies and their application in scientific or operational contexts. Advanced Experience with Biopharmaceutical Drug Substance, Analytical or Drug product Development, or Clinical Manufacturing. Excellent communication and stakeholder engagement skills. Masters degree in a related field with 12 years of experience or PhD with 8 years of experience Preferred Attributes Passion for innovation and digital transformation. Ability to translate scientific needs into practical, scalable digital solutions. Collaborative mindset with a strong focus on delivering measurable outcomes. Experience in leading other engineers/scientists in the creation, modification, and troubleshooting of laboratory robotics & automation scripts. The annual base pay for this position ranges from 171.426,40 - 257.139,60 USD Annual (80% - 120%). Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world. Join a team with the backing and investment to win! You'll be working with brand-new technology. This marriage between our purposeful work and the use of high-tech platforms is what sets us apart. Lead the way in digital healthcare. From exploring data and AI to working in the cloud on new technologies. Join a team at the forefront. Help shape and define the technologies of the future with the backing you need from across the business. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Ready to make an impact? Apply now! Date Posted 13-nov-2025 Closing Date 11-dic-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Job Title: Head of Material Planning About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: PCU Material Planner Team Member responsibilities are: Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations • Reporting of deviations to coverage targets to Critical Material Manager (GSP) Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements. Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days Assesses the availability of materials. Collaborate with the quality team to secure the release on-time for third party purchasing materials and the reflection of this time in the ERP system to ensure master data correctness Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue. Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them. Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level. Support warehouse and/or quality teams in complaint management and related deviations Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner. Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system. Ensures purchased materials are delivered in time for testing release and use. Monitor issues regarding shipping and returns. Track supplies' performance metrics. Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance. Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers. Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc. • Analyzes and proposes updates to Master Data to enhance industrial performance. Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs The PCU meeting roles of the PCU Material Planner Team Member are: Leads the MRP Meeting Contributes to the Level 1 Supply Chain +QDCI meeting Contributes to the Handover to Scheduler meeting Contributes to the Transparency meeting Contributes to Capability Review in case of capacity limiting Material Constraint CI loop contribution of PCU Material Planner Team Member includes: Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance. Takes responsibility for the availability of components to enable production orders. Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up. Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers) Key Involvement in Decision-Making Process Key Roles (D,A,I) A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical materials in alignment with Critical Material Manager GSP A/I: Key advisor in CI initiatives related to material planning, D: Takes care of implementation of CI initiatives A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI) About You Basic Qualifications Bachelor's Degree 10+ years of materials, purchasing or supply chain experience 5+ years of supervisory experience 5+ years of experience working with SAP and inventory management systems Excellent communication skills Proficient with MS office applications Preferred Qualifications Bachelor's Degree in a science or technical field Experience in pharmaceuticals or a related industry APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired Strong understanding of planning and purchasing systems in a CGMP manufacturing environment Project management skills Expertise in document management systems Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required. Solid understanding of quality, supply chain, finance and planning Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions Knowledge and experience with discrepancy investigation and lot disposition. Disclaimer The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $114,750.00 - $165,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

**Job Title:** Head of Material Planning **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** **PCU Material Planner Team Member responsibilities are:** + Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations - Reporting of deviations to coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions + Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements. + Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days + Assesses the availability of materials. + Collaborate with the quality team to secure the release on-time for third party purchasing materials and thereflection of this time in the ERP system to ensure master data correctness + Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue. + Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them. + Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level. + Support warehouse and/or quality teams in complaint management and related deviations + Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner. + Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review + Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system. + Ensures purchased materials are delivered in time for testing release and use. + Monitor issues regarding shipping and returns. + Track supplies' performance metrics. + Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance. + Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers. + Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc.- Analyzes and proposes updates to Master Data to enhance industrial performance. + Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs **The PCU meeting roles of the PCU Material Planner Team Member are:** + Leads the MRP Meeting + Contributes to the Level 1 Supply Chain +QDCI meeting + Contributes to the Handover to Scheduler meeting + Contributes to the Transparency meeting + Contributes to Capability Review in case of capacity limiting Material Constraint **CI loop contribution of PCU Material Planner Team Member includes:** + Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). + As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance. **Takes responsibility for the availability of components to enable production orders.** + Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up. + Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers) **Key Involvement in Decision-Making Process** **Key Roles (D,A,I)** + A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical + materials in alignment with Critical Material Manager GSP + A/I: Key advisor in CI initiatives related to material planning, + D: Takes care of implementation of CI initiatives + A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI) **About You** **Basic Qualifications** + Bachelor's Degree + 10+ years of materials, purchasing or supply chain experience + 5+ years of supervisory experience + 5+ years of experience working with SAP and inventory management systems + Excellent communication skills + Proficient with MS office applications **Preferred Qualifications** + Bachelor's Degree in a science or technical field + Experience in pharmaceuticals or a related industry + APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired + Strong understanding of planning and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems + Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required. + Solid understanding of quality, supply chain, finance and planning + Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with discrepancy investigation and lot disposition. **Disclaimer** The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. **Why Choose Us** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $114,750.00 - $165,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

**Job Title:** Head of Material Planning **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** **PCU Material Planner Team Member responsibilities are:** + Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations - Reporting of deviations to coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions + Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements. + Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days + Assesses the availability of materials. + Collaborate with the quality team to secure the release on-time for third party purchasing materials and thereflection of this time in the ERP system to ensure master data correctness + Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue. + Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them. + Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level. + Support warehouse and/or quality teams in complaint management and related deviations + Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner. + Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review + Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system. + Ensures purchased materials are delivered in time for testing release and use. + Monitor issues regarding shipping and returns. + Track supplies' performance metrics. + Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance. + Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers. + Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc.- Analyzes and proposes updates to Master Data to enhance industrial performance. + Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs **The PCU meeting roles of the PCU Material Planner Team Member are:** + Leads the MRP Meeting + Contributes to the Level 1 Supply Chain +QDCI meeting + Contributes to the Handover to Scheduler meeting + Contributes to the Transparency meeting + Contributes to Capability Review in case of capacity limiting Material Constraint **CI loop contribution of PCU Material Planner Team Member includes:** + Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). + As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance. **Takes responsibility for the availability of components to enable production orders.** + Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up. + Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers) **Key Involvement in Decision-Making Process** **Key Roles (D,A,I)** + A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical + materials in alignment with Critical Material Manager GSP + A/I: Key advisor in CI initiatives related to material planning, + D: Takes care of implementation of CI initiatives + A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI) **About You** **Basic Qualifications** + Bachelor's Degree + 10+ years of materials, purchasing or supply chain experience + 5+ years of supervisory experience + 5+ years of experience working with SAP and inventory management systems + Excellent communication skills + Proficient with MS office applications **Preferred Qualifications** + Bachelor's Degree in a science or technical field + Experience in pharmaceuticals or a related industry + APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired + Strong understanding of planning and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems + Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required. + Solid understanding of quality, supply chain, finance and planning + Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions + Knowledge and experience with discrepancy investigation and lot disposition. **Disclaimer** The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. **Why Choose Us** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $114,750.00 - $165,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************