Senior Manager, QS Change Management
hims & hers
PMP
Associate Director, Cell Therapy Technical Operations
Bristol Myers Squibb
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts, Washington
Visit company websiteSalary
💰 $185,580 - $231,184 per year
Job Level
Senior
About the role
- 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.
- Play a central role in PPQ readiness and regulatory submissions, and provide strategic oversight of external partners.
Requirements
- 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 and influencing external partnerships (CDMOs/CMOs).
- 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: Expertise in cell therapy, immunotherapy, or viral vector manufacturing.
- Preferred: Experience shaping and executing global strategy across multiple manufacturing sites.
- Preferred: Prior involvement in global governance forums or steering committees.
- Preferred: Familiarity with advanced statistical and QbD approaches for process lifecycle management.
