Bristol Myers Squibb
Associate Director/Director, Cell Therapy Technical Operations
Bristol Myers Squibb, Seattle, Washington, us, 98127
Position
Associate Director/Director, Cell Therapy Technical Operations
Within the Cell Therapy Development and Operations (CTDO) division, the Cell Therapy Technical Operations (CTTO) organization is accountable for technology transfer and process validation across the product lifecycle, CMC lifecycle management and regulatory strategy, oversight of global CDMO partnerships, and driving process engineering, harmonization, and standardization to enable global manufacturing scale-up, reliability, and regulatory compliance. The Technical Leader will define and execute strategies that enable the successful transfer, validation, and lifecycle management of cell therapy manufacturing processes, serving as a bridge between development, manufacturing, and external CDMOs to ensure technical alignment. The role will represent CTTO in global governance forums, provide strategic oversight of external partners, and shape standardized approaches, tools, and frameworks to enhance process robustness and scalability. The successful candidate will also drive alignment across the BMS network.
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 with:
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 and influencing 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 for this role includes location-specific ranges and may include incentive cash and stock opportunities based on eligibility. Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by location. For more information on benefits, visit the careers website.
Benefit offerings may include medical, pharmacy, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid holidays, vacation, volunteer days, parental and caregiver leave, adoption and surrogacy benefits, tuition reimbursement, and recognition programs. Specific offerings are subject to plan terms and applicable laws.
Working with Us Bristol Myers Squibb values balance and flexibility, offering a range of competitive benefits and programs to support employees in work and personal life. Read more at careers.bms.com/working-with-us.
Equal Opportunity BMS is committed to equal employment opportunity and compliance with applicable laws. Reasonable accommodations are available in the recruitment process; if accommodations are needed, contact adastaffingsupport@bms.com. For the full EEO statement, visit careers.bms.com/eeo-accessibility.
On-site Protocol BMS employs an occupancy structure that determines where work is conducted (site-essential, site-by-design, field-based, remote-by-design). The assigned occupancy type is based on role responsibilities and business needs. Site-essential roles require onsite presence; site-by-design roles may include a hybrid model; field-based and remote roles require travel as part of the job function.
Note: This posting includes other company job references in the page background; this refined description includes only the role-specific information above.
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Associate Director/Director, Cell Therapy Technical Operations
Within the Cell Therapy Development and Operations (CTDO) division, the Cell Therapy Technical Operations (CTTO) organization is accountable for technology transfer and process validation across the product lifecycle, CMC lifecycle management and regulatory strategy, oversight of global CDMO partnerships, and driving process engineering, harmonization, and standardization to enable global manufacturing scale-up, reliability, and regulatory compliance. The Technical Leader will define and execute strategies that enable the successful transfer, validation, and lifecycle management of cell therapy manufacturing processes, serving as a bridge between development, manufacturing, and external CDMOs to ensure technical alignment. The role will represent CTTO in global governance forums, provide strategic oversight of external partners, and shape standardized approaches, tools, and frameworks to enhance process robustness and scalability. The successful candidate will also drive alignment across the BMS network.
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 with:
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 and influencing 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 for this role includes location-specific ranges and may include incentive cash and stock opportunities based on eligibility. Final compensation is determined based on demonstrated experience. Eligibility for benefits varies by location. For more information on benefits, visit the careers website.
Benefit offerings may include medical, pharmacy, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid holidays, vacation, volunteer days, parental and caregiver leave, adoption and surrogacy benefits, tuition reimbursement, and recognition programs. Specific offerings are subject to plan terms and applicable laws.
Working with Us Bristol Myers Squibb values balance and flexibility, offering a range of competitive benefits and programs to support employees in work and personal life. Read more at careers.bms.com/working-with-us.
Equal Opportunity BMS is committed to equal employment opportunity and compliance with applicable laws. Reasonable accommodations are available in the recruitment process; if accommodations are needed, contact adastaffingsupport@bms.com. For the full EEO statement, visit careers.bms.com/eeo-accessibility.
On-site Protocol BMS employs an occupancy structure that determines where work is conducted (site-essential, site-by-design, field-based, remote-by-design). The assigned occupancy type is based on role responsibilities and business needs. Site-essential roles require onsite presence; site-by-design roles may include a hybrid model; field-based and remote roles require travel as part of the job function.
Note: This posting includes other company job references in the page background; this refined description includes only the role-specific information above.
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