Senior Manager, Pharmaceutical Development

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.

Responsibilities

• 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

Requirements

• 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