Associate Director, Manufacturing Technical Project Management (MSAT)
Core
Lead technical projects for commercial pharmaceutical manufacturing, primarily focusing on drug substance (API) activities at external contract manufacturing organizations (CMOs) and supporting end-to-end CMC initiatives.
Role type
Senior IC Manufacturing Technical Project Manager (MSAT) with team leadership responsibilities
Builds
Drug substance manufacturing capabilities, technology transfers, and supply readiness for novel therapeutics
Domain
Biopharmaceuticals / Small-molecule drug substance manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical manufacturing project management, external CMO coordination, technology transfer management, lifecycle change management, cross-functional stakeholder alignment, risk-based problem solving, team scaling and development, GMP compliance awareness
Preferred skills
Small-molecule drug substance manufacturing experience, end-to-end CMC project management, regulated environment team leadership, PMP certification
Technologies
GMP environments, CMO management systems, project governance tools
Responsibilities
Lead MSAT technical projects supporting commercial manufacturing with primary focus on drug substance (API) activities at external CMOs; Develop and manage integrated project plans, timelines, and deliverables for technical initiatives; Lead and develop a blended team of MSAT project managers covering both internal and contingent resources; Serve as the primary MSAT project interface with CMOs for assigned initiatives; Manage projects related to API technology transfer, process changes, site onboarding, and manufacturing readiness; Identify, track, and escalate technical and execution risks related to manufacturing projects
Seniority
Senior, hands-on IC with team leadership