Director, Vector Product Champion
New Today
Overview
The Director, Vector Product Champion is accountable for leading an interdisciplinary technical team of scientists and engineers to manage the technical life cycle of Cell Therapy clinical and commercial products. This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks, and ensuring technical alignment with stakeholders.
As a key member of the CMC and Global Operations (GO) Team, the Product Champion will deliver technical projects aligned to the brand strategy and Global Product Strategy (GPS) goals. Success is measured by maintaining supply continuity, meeting project milestones, achieving regulatory approvals, and delivering on process robustness goals. Depending on workload and complexity, the Product Champion may manage one or more products.
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.
- Author, review and approve regulatory CMC submission sections.
- Drive continuous improvement initiatives to improve lifecycle management and process robustness.
- Actively manage technical risks & risk register, charter priority projects to manage high risks to the brand, and support business continuity initiatives.
- Escalate risk and develop contingency plans through proactive stakeholder engagement.
- Provide leadership updates on brand strategy, technical risk and the overall health of priority projects.
Qualifications & Experience
- 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.
- 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).
- Excellent interpersonal, collaborative, team building and communication skills.
- Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues.
- Approximately 10-20% travel.
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment
- Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadership.
Compensation & Benefits
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include: Medical, pharmacy, dental and vision care; wellbeing programs; 401(k); disability and life insurance; travel protection; paid holidays and vacation; paid time off for volunteering; parental, caregiver, bereavement, and military leave; family support resources; tuition reimbursement and recognition programs.
- Location:
- Seattle
- Salary:
- $250,000 +
- Job Type:
- FullTime
- Category:
- Management & Operations
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