*On site role in San Diego*
A clinical-stage biopharmaceutical company is looking to hire a Senior Manager of CMC to join their team as an individual contributor to support their external partners. The companies pipeline consists of small molecule drug candidates focused on oncology.
Responsibilities
- Subject matter expert for all aspects of drug substance
- Monitor work performed by CDMOs, including review of protocols, reports, and raw data
- Identify development risks/gaps and lead studies to control them
- Establish and oversee phase appropriate process development plans for drug substance
- Ability to travel domestically as needed
- Working knowledge of ICH guidelines related to cGMP, technology transfers, manufacturing records review and approval
Qualifications
- B.S./M.S. in Chemistry, Organic Chemistry, or related field with 8+ years of experience or Ph.D. with 5+ years of experience
- Expertise in drug substance production techniques, processing, and characterization of API materials
- Prior experience working and managing CDMOs, and CROs
- Ability to work with diverse stakeholders, both internally and externally
