Senior Manager, Manufacturing

Corcept Therapeutics seeks a Senior Manager for Drug Substance Manufacturing to oversee late-stage and commercial small molecule active pharmaceutical ingredient production. The role manages external contract manufacturing organizations, ensures GMP compliance, and coordinates process validation and regulatory readiness across multiple development programs.

Responsibilities

• Lead and manage external GMP drug substance manufacturing for late-phase small molecule API programs
• Oversee non-GMP starting material and key intermediate manufacture; manage external partner activities and documentation
• Assess risks associated with starting material sourcing, supplier reliability, and impact on downstream GMP manufacturing
• Support technology transfer, scale-up, process optimization, and commercial launch preparation activities
• Serve as primary technical interface with contract manufacturers for campaign execution and batch record approval

Requirements

• Extensive experience in small molecule API manufacturing and GMP operations
• Demonstrated expertise in late-stage CMC development and process transfer
• Strong knowledge of process validation, deviation investigation, and change control
• Experience managing contract manufacturing organizations and external suppliers
• Cross-functional collaboration skills with Quality, Regulatory, and Supply Chain teams
• Technical proficiency in batch record review and manufacturing documentation