Lead diagnostics development and commercialization for GSK's Oncology portfolio. Manage cross - functional teams to deliver innovative diagnostics while ensuring compliance with regulations.
About the role
- Director leading interdisciplinary technical team at Bristol Myers Squibb for managing Cell Therapy products. Responsible for developing and executing CMC strategy, ensuring regulatory approvals, and delivering process robustness goals.
Responsibilities
- Lead a cross functional matrix team (CTTO, Development, Analytical, Quality, External Manufacturing, and Regulatory) to create an integrated technical roadmap for Key Vector assets.
- 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.
Requirements
- 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.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Director of Major Gifts enhancing individual giving for Chicago Abortion Fund. Leading major gifts and planned giving initiatives with high - net - worth individuals to secure significant commitments.
Regional Liaison Director leading the Field Medical Affairs team at AstraZeneca. Executing medical strategies to transform cardiovascular and renal care.
Director of After School Programs at Camp Fire Alaska empowering youth through community programs and partnerships. Leading teams and ensuring quality across after - school initiatives in Anchorage, Alaska.
Adjoint Director managing medical and social establishments in France. Leading strategic projects and coordinating resources with a focus on patient care and quality improvement.
Publishing Director responsible for driving commercial growth and audience engagement in B2B media. Leading strategic decisions across a portfolio of brands in a hybrid work environment.
Director leading the Influencer & Celebrity Relations team at BPCM, a women - led PR agency. Collaborating with teams across LA, NY, and London to drive celebrity partnerships.
Leadership role for developing strategies and expanding partnerships in an international exhibition context. Overseeing a team and contributing to the growth of Fruit Logistica, a major global trade fair.
Senior Director, Strategy responsible for driving client acquisition and business development for pharmaceutical and biotech partners. Collaborating with Insights teams and leading sales strategies.
Director of Maintenance overseeing all maintenance operations at a healthcare facility. Responsible for safety, compliance, team management, and budget oversight.