Senior Manager, Pharmaceutical Development
Erasca · South San Francisco, CA
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Role summary
Erasca seeks a Senior Manager of Pharmaceutical Development to oversee small molecule drug product manufacturing at contract partners. The role involves formulation development, GMP compliance, regulatory submissions, and cross-functional coordination for an oncology-focused company.
What they're looking for
- Advanced degree (MS/PhD) in Pharmaceutics, Chemistry, or related field; or BS with 10+ years experience
- 7+ years (MS) or 10+ years (BS) progressive pharmaceutical small molecule development experience
- Hands-on expertise in solid oral dosage formulation, excipient selection, stability design, and scale-up
- Direct CDMO collaboration experience including person-in-plant oversight and technology transfer
- Knowledge of cGMP, ICH guidelines, and FDA/global regulatory requirements
- Ability to support global operations across time zones and respond to manufacturing issues
What you'll be doing
- Design and execute formulation and process development for oral solid dosage forms
- Manage GMP manufacturing at CDMOs, directing operations and approving batch records and regulatory documents
- Support registration activities including design of experiments, scale-up, and tech transfer
- Provide technical support for manufacturing investigations, deviations, and corrective actions
- Author regulatory submissions (IND, IMPD, NDA, MAA); travel approximately 25% including domestic and international site visits
Privacy & handoff
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