Bristol Myers Squibb
Associate Director / Director, Drug Product Lifecycle Management
Bristol Myers Squibb, Seattle, Washington, us, 98127
Position Summary
The Associate Director / Director of Drug Product Lifecycle Management within Cell Therapy Technical Operations (CTTO) leads a high‑performing technical team responsible for the strategy, execution, and implementation of all global lifecycle projects for designated cell therapy products. This role is pivotal in driving innovation, operational excellence, and regulatory compliance across multiple global manufacturing sites, with a direct impact on patient outcomes. Reporting to senior leadership, the Director partners with matrixed technical teams and multifunctional stakeholders to shape the strategic technology roadmap for cell therapy manufacturing, setting standards and directives for manufacturing operations and providing specialized expertise to support site capabilities, investigations, and process improvements.
Key Responsibilities
Develop and execute the global strategy for cell therapy manufacturing process changes, ensuring alignment with commercial and CMC objectives.
Own the technical project portfolio for designated cell therapy products, managing schedules, budgets, and resources.
Lead cross‑functional matrix teams to deliver process transformation, improvement, and cost reduction initiatives.
Drive alignment across CTTO, analytical, quality, regulatory, operations, development, supply chain, program strategy, third‑party manufacturing, and manufacturing sites.
Implement lifecycle management projects and harmonize manufacturing processes across multiple sites.
Lead Manufacturing Success Rate (MSR), Robustness, and Cost Reduction initiatives to ensure reliable drug product supply and continuous commercial process transformation.
Oversee process validation, technology transfer, process qualification, and comparability strategies.
Lead continuous improvement projects and change control management to enhance product quality, compliance, and supply reliability.
Lead and oversee the technical package, including project and process risk assessments, governance presentations, and standalone actions to ensure effective project execution.
Lead and oversee global change controls, CAPAs, proactive initiatives, and standalone actions to maintain compliance and drive improvement.
Author and review technical content for regulatory submissions (e.g., PPQ, comparability assessments), annual product quality reviews, and technical reports.
Manage and mentor a technical team, assigning projects and tasks based on strategic priorities.
Foster a culture of accountability, inclusion, integrity, and innovation.
Promote diversity, equity, and inclusion in team composition and project execution.
Qualifications & Experience
Bachelor's degree or higher in Engineering, Life Sciences, Biology, Chemistry, Biochemical/Chemical Engineering, or related technical discipline.
Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.
14+ years of relevant experience in cell therapy, biologics, or pharmaceutical manufacturing.
Proven leadership of technical teams and project in a matrixed environment.
Expertise in cGMP operations, technology transfer, process validation, regulatory compliance, and change management.
Deep knowledge of Cell Therapy Drug Product Manufacturing and sterile drug product operations.
Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
Excellent strategic thinking, problem‑solving, decision‑making, and communication skills.
Familiarity with project management tools and Lean Six Sigma methodologies is a plus.
Ability to travel up to 20%.
Compensation Overview Devens – MA
– US $214,250 – $259,622 Seattle – WA
– $220,250 – $266,894 Summit West – NJ
– US $200,230 – $242,637
Benefits BMS offers a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives. Medical, pharmacy, dental, and vision care, wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP), financial well‑being resources and a 401(k), short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support, paid national holidays, optional holidays, up to 120 hours of paid vacation, two paid volunteer days, sick time, summer hours flexibility, parental, caregiver, bereavement, and military leave, family care services, tuition reimbursement and a recognition program.
EEO Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. BMS cares about your well‑being and the well‑being of our staff, customers, patients, and communities. All employees are strongly recommended to be fully vaccinated for Covid‑19 and keep up to date with Covid‑19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. BMS will provide equal employment opportunity to all applicants and employees. For more information, visit careers.bms.com/eeo -accessibility.
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Key Responsibilities
Develop and execute the global strategy for cell therapy manufacturing process changes, ensuring alignment with commercial and CMC objectives.
Own the technical project portfolio for designated cell therapy products, managing schedules, budgets, and resources.
Lead cross‑functional matrix teams to deliver process transformation, improvement, and cost reduction initiatives.
Drive alignment across CTTO, analytical, quality, regulatory, operations, development, supply chain, program strategy, third‑party manufacturing, and manufacturing sites.
Implement lifecycle management projects and harmonize manufacturing processes across multiple sites.
Lead Manufacturing Success Rate (MSR), Robustness, and Cost Reduction initiatives to ensure reliable drug product supply and continuous commercial process transformation.
Oversee process validation, technology transfer, process qualification, and comparability strategies.
Lead continuous improvement projects and change control management to enhance product quality, compliance, and supply reliability.
Lead and oversee the technical package, including project and process risk assessments, governance presentations, and standalone actions to ensure effective project execution.
Lead and oversee global change controls, CAPAs, proactive initiatives, and standalone actions to maintain compliance and drive improvement.
Author and review technical content for regulatory submissions (e.g., PPQ, comparability assessments), annual product quality reviews, and technical reports.
Manage and mentor a technical team, assigning projects and tasks based on strategic priorities.
Foster a culture of accountability, inclusion, integrity, and innovation.
Promote diversity, equity, and inclusion in team composition and project execution.
Qualifications & Experience
Bachelor's degree or higher in Engineering, Life Sciences, Biology, Chemistry, Biochemical/Chemical Engineering, or related technical discipline.
Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.
14+ years of relevant experience in cell therapy, biologics, or pharmaceutical manufacturing.
Proven leadership of technical teams and project in a matrixed environment.
Expertise in cGMP operations, technology transfer, process validation, regulatory compliance, and change management.
Deep knowledge of Cell Therapy Drug Product Manufacturing and sterile drug product operations.
Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
Excellent strategic thinking, problem‑solving, decision‑making, and communication skills.
Familiarity with project management tools and Lean Six Sigma methodologies is a plus.
Ability to travel up to 20%.
Compensation Overview Devens – MA
– US $214,250 – $259,622 Seattle – WA
– $220,250 – $266,894 Summit West – NJ
– US $200,230 – $242,637
Benefits BMS offers a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives. Medical, pharmacy, dental, and vision care, wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP), financial well‑being resources and a 401(k), short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support, paid national holidays, optional holidays, up to 120 hours of paid vacation, two paid volunteer days, sick time, summer hours flexibility, parental, caregiver, bereavement, and military leave, family care services, tuition reimbursement and a recognition program.
EEO Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. BMS cares about your well‑being and the well‑being of our staff, customers, patients, and communities. All employees are strongly recommended to be fully vaccinated for Covid‑19 and keep up to date with Covid‑19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. BMS will provide equal employment opportunity to all applicants and employees. For more information, visit careers.bms.com/eeo -accessibility.
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