Bristol Myers Squibb is looking to fill the role of Director, Vector Product Champion to lead an interdisciplinary technical team in managing the technical life cycle of Cell Therapy clinical and commercial products, ensuring supply continuity, meeting project milestones, achieving regulatory approvals, and delivering on process robustness goals.
Requirements
- Direct experience in participating on and leading technical project teams in a highly matrixed environment.
- Proven track record managing and influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes.
- Knowledge of CMC regulatory, drug substance & drug product manufacturing, and analytical testing requirements is strongly preferred.
- Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.
- Ability to effectively utilize project management and Lean Six Sigma tools is a plus.
- Experience authoring and defending regulatory submissions (INDs, BLAs, variations).
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment
Responsibilities
- Lead a cross functional matrix team (CTTO, Development, Analytical, Quality, External Manufacturing, and Regulatory) to create an integrated technical product roadmap.
- Develop CMC technical strategy for life cycle or pipeline programs; secure stakeholder endorsement at governance forums.
- Partner with matrix team leads to build project schedules, charters, budgets, and resourcing plans.
- Define and drive global process control strategies, including risk-based parameter classification, lifecycle justification of ranges, and Continued Process Verification (CPV) alignment.
- Develop end-to-end project to portfolio execution, focused on supply stabilization, business continuity projects, and pipeline launch programs.
- Represent CTTO in regulatory discussions and serve as a technical leader for INDs, and BLAs.
- Participate in global change control management to ensure product quality, compliance and supply.
Other
- Approximately 10-20% travel.
- Excellent interpersonal, collaborative, team building and communication skills.
- Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues.
- Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadership.
- B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline with: 15+ years (B.S.), 15+ years (M.S.), or 12+ years (Ph.D.) of experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support.
