Senior Director, CMC Team Leader
Bristol Myers Squibb
August 06, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Primary Responsibilities:
- Lead interdisciplinary matrix teams to develop and execute compound-specific integrated CMC strategies (drug substance, drug product, analytical, quality, regulatory, clinical supplies) to advance R&D objectives.
- Represent GPS on key R&D Project Teams; collaborate with Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc. to develop globally optimized program strategies.
- Define and execute CMC strategy; communicate/partner with stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing); identify/escalate key issues, risks, and resource needs.
- Accountable for multiple assets across modalities and development phases (candidate nomination through BLA/NDA approvals), partnering with the CMC Team Project Manager.
- Own CMC project budget; use financial acumen/ROI mindset to assess portfolio trends and inform investment decisions.
- Influence CMC regulatory strategies; review CMC submissions, briefing booklets, and information requests.
- Drive operational excellence and strategic improvements (best practices, digital/planning tools, program simulation); support Due Diligence and alliance/asset integration.
Qualifications/Skills:
Senior Director (15+ yrs CMC; advanced degree): strategic planning; strong communication/problem-solving; partnership leadership; risk-balanced investment; lead/inspire teams; manage ambiguity; modality experience (clear plus); deep CMC/formulation/analytical expertise; CMO/supply chain + budget; innovative CMC solutions; global regulatory knowledge (FDA/EMA/ICH); collaborative/inclusive values.
Director (12+ yrs CMC; advanced degree): strong matrix influence; investment strategy/risk principles; enterprise leadership; broad CMC lifecycle experience; modality experience (clear plus); strategic/tactical project leadership.
Compensation/Benefits (as stated): $234,100–$283,672; health, wellbeing, 401(k), disability/life, and paid time off.
Application instruction:
- If not an exact match, apply anyway.
- Lead interdisciplinary matrix teams to develop and execute compound-specific integrated CMC strategies (drug substance, drug product, analytical, quality, regulatory, clinical supplies) to advance R&D objectives.
- Represent GPS on key R&D Project Teams; collaborate with Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc. to develop globally optimized program strategies.
- Define and execute CMC strategy; communicate/partner with stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing); identify/escalate key issues, risks, and resource needs.
- Accountable for multiple assets across modalities and development phases (candidate nomination through BLA/NDA approvals), partnering with the CMC Team Project Manager.
- Own CMC project budget; use financial acumen/ROI mindset to assess portfolio trends and inform investment decisions.
- Influence CMC regulatory strategies; review CMC submissions, briefing booklets, and information requests.
- Drive operational excellence and strategic improvements (best practices, digital/planning tools, program simulation); support Due Diligence and alliance/asset integration.
Qualifications/Skills:
Senior Director (15+ yrs CMC; advanced degree): strategic planning; strong communication/problem-solving; partnership leadership; risk-balanced investment; lead/inspire teams; manage ambiguity; modality experience (clear plus); deep CMC/formulation/analytical expertise; CMO/supply chain + budget; innovative CMC solutions; global regulatory knowledge (FDA/EMA/ICH); collaborative/inclusive values.
Director (12+ yrs CMC; advanced degree): strong matrix influence; investment strategy/risk principles; enterprise leadership; broad CMC lifecycle experience; modality experience (clear plus); strategic/tactical project leadership.
Compensation/Benefits (as stated): $234,100–$283,672; health, wellbeing, 401(k), disability/life, and paid time off.
Application instruction:
- If not an exact match, apply anyway.