New Product Introduction Lead
Core
Lead the introduction of new biopharmaceutical products into the manufacturing plant, managing technology transfer, project planning, and cross-functional collaboration to ensure on-time launch.
Role type
Senior Associate Manufacturing (New Product Introduction Lead)
Builds
New drug product manufacturing programs for clinical and commercial use
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Technology transfer project planning, GMP compliance, root cause analysis, change control management, cross-functional leadership, quantitative troubleshooting, regulatory compliance knowledge
Preferred skills
Drug product formulation knowledge, vial/syringe filling operations experience, project management, technical writing, regulated environment experience
Technologies
Trackwise, CDOCS (Veeva)
Responsibilities
Develop and maintain NPI project plans, resolve manufacturing issues via root cause analysis, own change controls in Trackwise, manage NPI records in CDOCS, lead cross-functional meetings, perform Gemba walks for process improvement
Seniority
Senior, hands-on IC
