Bristol Myers Squibb
Associate Director, Cell Therapy Technical Operations
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Overview
Associate Director/Director, Cell Therapy Technical Operations at Bristol Myers Squibb. This role is within the Cell Therapy Development and Operations (CTDO) division and the CTTO organization, accountable for technology transfer, process validation, CMC lifecycle management and regulatory strategy, governance of global CDMO partnerships, and driving process engineering and standardization for global manufacturing scale-up, reliability, and regulatory compliance. Primary Responsibilities
Provide strategic leadership for cross-functional technology transfers, including facility fit, readiness, and long-term manufacturing sustainability. Define and drive global process control strategies, ensuring risk-based parameter classification, lifecycle justification of ranges, and alignment with CPV methodologies. Represent CTTO in regulatory discussions and serve as a technical leader for INDs and BLAs. Establish and maintain strong partnerships with CDMOs, acting as the primary technical interface to ensure performance, alignment, and compliance with BMS standards. Lead global forums to harmonize manufacturing processes, control strategies, and lifecycle management approaches across internal and external sites. Partner with senior leadership to influence long-term CTTO strategy, identifying opportunities for innovation, standardization, and operational excellence. Monitor and interpret process performance data to inform strategic decision-making, lifecycle investments, and continuous improvement. Provide mentorship and technical leadership to junior engineers, elevating organizational capability through best-practice sharing. Required Qualifications
B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline. 10+ years (B.S.), 8+ years (M.S.), or 5+ years (Ph.D.) of experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support. Demonstrated success leading late-stage development, PPQ strategy, and commercial validation. Proven track record managing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks. Experience authoring and defending regulatory submissions (INDs, BLAs, variations). Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues. Proficiency in data analytics and modeling tools (e.g., JMP, R, Minitab). Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadership. Preferred Qualifications
Expertise in cell therapy, immunotherapy, or viral vector manufacturing. Experience shaping and executing global strategy across multiple manufacturing sites. Prior involvement in global governance forums or steering committees. Familiarity with advanced statistical and QbD approaches for process lifecycle management. Compensation and Benefits
The compensation overview notes ranges for locations (e.g., Devens, MA; Seattle, WA) and that starting compensation is based on experience, with additional incentive cash and stock opportunities where eligible. Benefits vary by role and location and may include medical/dental/vision, wellbeing resources, retirement plans, disability and life insurance, leave programs, and other perks. Exact offers are determined based on demonstrated experience and location. On-site and Eligibility Information
On-site presence requirements vary by role (site-essential, hybrid, field-based). Bristol Myers Squibb is committed to an accessible recruitment process with reasonable accommodations available upon request. For inquiries, contact adastaffingsupport@bms.com. See the Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. Additional Details
Seniority level: Director. Employment type: Full-time. Job function: Other. Industry: Pharmaceutical Manufacturing.
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Associate Director/Director, Cell Therapy Technical Operations at Bristol Myers Squibb. This role is within the Cell Therapy Development and Operations (CTDO) division and the CTTO organization, accountable for technology transfer, process validation, CMC lifecycle management and regulatory strategy, governance of global CDMO partnerships, and driving process engineering and standardization for global manufacturing scale-up, reliability, and regulatory compliance. Primary Responsibilities
Provide strategic leadership for cross-functional technology transfers, including facility fit, readiness, and long-term manufacturing sustainability. Define and drive global process control strategies, ensuring risk-based parameter classification, lifecycle justification of ranges, and alignment with CPV methodologies. Represent CTTO in regulatory discussions and serve as a technical leader for INDs and BLAs. Establish and maintain strong partnerships with CDMOs, acting as the primary technical interface to ensure performance, alignment, and compliance with BMS standards. Lead global forums to harmonize manufacturing processes, control strategies, and lifecycle management approaches across internal and external sites. Partner with senior leadership to influence long-term CTTO strategy, identifying opportunities for innovation, standardization, and operational excellence. Monitor and interpret process performance data to inform strategic decision-making, lifecycle investments, and continuous improvement. Provide mentorship and technical leadership to junior engineers, elevating organizational capability through best-practice sharing. Required Qualifications
B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline. 10+ years (B.S.), 8+ years (M.S.), or 5+ years (Ph.D.) of experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support. Demonstrated success leading late-stage development, PPQ strategy, and commercial validation. Proven track record managing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks. Experience authoring and defending regulatory submissions (INDs, BLAs, variations). Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues. Proficiency in data analytics and modeling tools (e.g., JMP, R, Minitab). Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadership. Preferred Qualifications
Expertise in cell therapy, immunotherapy, or viral vector manufacturing. Experience shaping and executing global strategy across multiple manufacturing sites. Prior involvement in global governance forums or steering committees. Familiarity with advanced statistical and QbD approaches for process lifecycle management. Compensation and Benefits
The compensation overview notes ranges for locations (e.g., Devens, MA; Seattle, WA) and that starting compensation is based on experience, with additional incentive cash and stock opportunities where eligible. Benefits vary by role and location and may include medical/dental/vision, wellbeing resources, retirement plans, disability and life insurance, leave programs, and other perks. Exact offers are determined based on demonstrated experience and location. On-site and Eligibility Information
On-site presence requirements vary by role (site-essential, hybrid, field-based). Bristol Myers Squibb is committed to an accessible recruitment process with reasonable accommodations available upon request. For inquiries, contact adastaffingsupport@bms.com. See the Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility. Additional Details
Seniority level: Director. Employment type: Full-time. Job function: Other. Industry: Pharmaceutical Manufacturing.
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