- South San Francisco, California, United States
- On-site
- Full-time · Manager
- $206K–$254K per year
- 10+ years
Lead Process Chemistry efforts to develop drug substance and support CMC regulatory submissions for oncology therapies.
Compensation
The expected salary range for the role of Director, CMC Process Chemistry is $206,000 - $254,000.
Responsibilities
- Lead Process Chemistry efforts in facilitating drug substance development
- Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations
- Author and review necessary technical sections in IND/IMPD/NDA documents supporting global CMC regulatory submissions
- Represent DS/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment
- Collaborate closely in cross-functional teams including Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology
Requirements
- Ph.D. in Chemistry
- M.Sc. in Chemistry
- Nice to have: late phase and commercial experience
- Nice to have: small molecule ADC payload/linker experience