Associate Director, Cell Therapy Technical Operations
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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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 and governance of global CDMO partnerships
Driving process engineering, harmonization, and standardization to ensure global manufacturing scale-up, reliability, and regulatory compliance
We are seeking a strong strategic technical leader to join our Global MSAT team partnering with internal and external stakeholders to shape the future of cell therapy manufacturing.
The Technical Leader will be responsible for defining and executing strategies that enable the successful transfer, validation, and lifecycle management of cell therapy manufacturing processes. This role will serve as a bridge between development, manufacturing, and external CDMOs, and ensuring technical alignment.
The successful candidate will represent CTTO in global governance forums, provide strategic oversight of external partners, and play a central role in PPQ readiness, and regulatory submissions. They will also drive alignment across the BMS network by shaping standardized approaches, tools, and frameworks that enhance process robustness and scalability.
Key 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, while also elevating organizational capability through best practice sharing.
Basic 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.
- Location:
- Devens
- Job Type:
- FullTime