NPI Project Manager
Core
End-to-end execution of New Product Introduction (NPI) programs from award through commercialization for biopharma clients, ensuring regulatory compliance and operational readiness.
Role type
Senior IC NPI Project Manager
Builds
NPI programs, manufacturing readiness, and commercialization pipelines for biopharma clients
Domain
Biopharmaceuticals / Contract Manufacturing / GMP
Required skills
NPI lifecycle management, cross-functional coordination, stage-gate management, risk escalation, regulatory compliance (cGMP/FDA), project planning, stakeholder communication
Preferred skills
Tech transfer, process validation (PLT/PQ/PPQ), commercial manufacturing readiness, drug product manufacturing knowledge, stage-gate methodologies
Technologies
Smartsheet, Microsoft 365
Responsibilities
Own end-to-end project execution from award to commercialization; drive cross-functional coordination across Engineering, QA, Operations, and Supply Chain; lead client steering committee meetings; manage NPI stage gates and ensure regulatory submission readiness; monitor project scope, costs, and timelines; coordinate technology transfer and validation activities
Seniority
Senior, hands-on IC