Senior Director, CMC Drug Substance Development & Manufacturing
Olema Oncology(1 month ago)
About this role
The Senior Director, CMC Drug Substance Development & Manufacturing will lead Olema’s drug substance CMC strategy for late-stage and commercial programs, ensuring regulatory readiness and high-quality supply. This role partners across functions and with external CDMO partners to support technical development, transfers, and regulatory submissions. The position is based in San Francisco or Boston and reports to the SVP of CMC & Supply Chain.
Required Skills
- Project Leadership
- Process Development
- Manufacturing
- CMO Management
- Technical Transfer
- Process Validation
- Analytical Methods
- Document Review
- Change Control
- Investigations
+5 more
Qualifications
- Ph.D. in Organic Chemistry or Related Discipline
- Master's Degree
About Olema Oncology
olema.comOlema Oncology is a cancer medicines company focused on innovating therapies for breast cancer and other endocrine-driven tumors. The company is rapidly advancing a pipeline of drug candidates designed to target the biology of endocrine-driven disease. Olema’s work centers on translating cutting‑edge science into treatments that meaningfully impact patients, progressing programs toward clinical evaluation.
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