Manager, Product Development GMP Operations
Core
Lead GMP manufacturing and packaging operations for early-phase clinical trial drug products.
Role type
Manager, Product Development GMP Operations
Builds
Early-phase clinical trial drug products
Domain
Pharmaceutical manufacturing / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP drug product manufacturing, cGMP regulations, team leadership, facility design oversight, regulatory compliance, stakeholder management
Preferred skills
Engineering build-out collaboration, audit readiness, strategic growth initiatives
Technologies
GMP facilities, engineering drawings, equipment selection
Responsibilities
Lead and develop GMP manufacturing and packaging operations, Design and oversee PD GMP spaces, Serve as technical SME for PD GMP activities, Provide leadership for technical teams, Ensure compliance with cGMPs and regulatory requirements, Coordinate with cross-functional teams
Seniority
Manager, hands-on leadership
