API Manufacturing Manager
Core
Oversees relationships, contracts, and activities of API commercial contract manufacturing organizations (CMOs) within the supply chain network.
Role type
Senior IC API Manufacturing Manager
Builds
Commercial API supply chain operations and product availability
Domain
Biopharmaceutical / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
API CMC manufacturing, tech transfer, validation, commercial scale production, cGMP compliance, risk management (FMEA), process improvement (Lean/Six Sigma/CPV), contract negotiation, supplier management, project planning, resource management
Preferred skills
Experience with solid oral dosage products, drug substance or packaging operations, experience with marketed products, US/EU regulatory knowledge
Technologies
None explicitly listed
Responsibilities
Lead cross-functional teams and CMOs to determine manufacturing plans and mitigate risks; Manage operational activities (schedule, timelines, cost) of CMOs to meet objectives; Review and approve pre- and post-production documents; Support validation activities for commercial products; Partner with Quality Assurance to ensure cGMP compliance; Analyze and champion process improvements; Support preparation and negotiation of RFQs, RFPs, SOWs, and Supply Agreements
Seniority
Senior, hands-on IC
