Senior Manager, Manufacturing

The role

This person will support late-stage development and commercial readiness for small molecule active pharmaceutical ingredients. They will manage external manufacturing activities at contract manufacturing organizations and oversee GMP and non-GMP manufacturing processes.

What you will do

• Lead and manage external GMP drug substance manufacturing activities for late phase small molecule API programs
• Oversee manufacture and supply of regulatory starting materials and key intermediates under non-GMP conditions
• Manage external partners involved in non-GMP starting material manufacture
• Partner with Process Chemistry, Quality, Regulatory, and Supply Chain teams
• Assess risks associated with starting material sourcing and manufacture
• Support supplier qualification, technical assessments, and lifecycle management activities
• Oversee technology transfer, scale-up, process optimization, engineering batches, PPQ readiness, and commercial launch preparation
• Serve as the primary technical and operational interface with CMOs
• Review and approve batch records, campaign protocols, manufacturing instructions, process validation protocols, and manufacturing reports
• Support process validation strategy, including PPQ planning, continued process verification, and process performance monitoring

Required qualifications

• Master’s or Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline
• 8+ years of relevant experience with a Master’s degree, or 5+ years with a Ph.D
• Strong experience in small molecule API manufacturing
• Demonstrated experience working with CMOs and managing external manufacturing campaigns
• Experience managing non-GMP manufacture of regulatory starting materials, advanced intermediates, or key raw materials used in small molecule API manufacturing
• Solid understanding of cGMP requirements, ICH Q7, ICH Q11, process validation, and regulatory expectations for API manufacturing
• Experience with process transfer, scale-up, PPQ preparation, deviation investigations, CAPAs, and change controls
• Strong technical understanding of synthetic organic chemistry, impurity control, process parameters, in-process controls, and manufacturing documentation

Nice to have

• Direct experience supporting NDA, MAA, or commercial launch readiness for small molecule APIs
• Experience with post-approval changes, process validation lifecycle, continued process verification, and regulatory inspection support
• Familiarity with quality risk management principles and impurity control strategies, including genotoxic impurities and nitrosamine risk assessments
• Experience supporting supplier qualification, raw material change assessments, and CMO audits
• Prior experience in outsourced development/manufacturing models
• Strong technical judgment and problem-solving skills
• Ability to lead through influence in a cross-functional matrix environment
• High attention to detail and commitment to GMP compliance
• Effective communication with internal stakeholders and external manufacturing partners
• Strong ownership, accountability, and ability to drive deliverables to completion

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.