Senior Director, CMC Drug Substance Development & Manufacturing
Olema Oncology(1 month ago)
About this role
The Senior Director, CMC Drug Substance Development & Manufacturing is a senior scientific leader responsible for overseeing late-stage process development and the technical aspects of drug substance manufacturing for small-molecule programs. The role supports preparation and review of CMC documentation for regulatory submissions and partners with cross-functional teams including quality, regulatory affairs, and supply chain. This position is site-based in San Francisco or Boston and requires approximately 10% travel.
Required Skills
- Process Development
- Manufacturing
- CMO Management
- Tech Transfer
- Process Validation
- Analytical Methods
- Documentation Review
- Deviation Investigation
- Quality Assurance
- Regulatory Affairs
+4 more
Qualifications
- Ph.D. in Organic Chemistry
- Master's in Related Discipline
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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