Associate Director, External Development and Manufacturing, Drug Product
Core
Leads external formulation, device, and process development and GMP manufacturing activities for drug products and devices across small- and large-molecule R&D.
Role type
Senior IC Associate Director, External Development and Manufacturing
Builds
Drug product and device sourcing strategy, external manufacturing network, and clinical supply for oral solids, biologics, vaccines, and drug-device combinations.
Domain
Pharmaceutical Sciences / Drug Product Manufacturing / Contract Manufacturing
Required skills
Vendor Management, GMP Compliance, Clinical Manufacturing, Project Management, Risk Management, Solid Dosage Forms, Process Development, Regulatory Compliance, Strategic Sourcing, Cross-functional Collaboration
Preferred skills
Business Process Optimization, SAP, Device Development, Continuous Improvement
Technologies
SAP
Responsibilities
Plan and coordinate formulation, device, process development, and clinical manufacturing activities at CROs/CMOs; Evaluate RFPs and recommend vendors based on technical fit, capacity, and geography; Establish and maintain trusted vendor relationships aligned with pipeline needs; Collaborate across scientific and operational functions to optimize externalization activities and advance operational excellence.
Seniority
Senior, hands-on IC with strategic oversight