Program Manager, MES
Core
Organize and lead cross-functional teams for the planning and execution of programs associated with the assembly, labeling, and packaging of drug delivery devices and combination products, ensuring successful tech transfer and commercialization.
Role type
Senior Program Manager (Manufacturing/Pharma)
Builds
Drug delivery devices and combination products
Domain
Pharmaceutical manufacturing and supply chain
Required skills
Cross-functional team leadership, GMP manufacturing knowledge, Supply chain management, Validation expertise, CMC technical development, Pharmaceutical regulations, Project management, Budget management, Risk mitigation, Multi-site operations
Preferred skills
PMP certification, Multiple languages
Technologies
GMP, CMC, Validation tools
Responsibilities
Assemble and lead matrixed cross-functional teams for process development and manufacturing; Implement site transfers, new indications, and lifecycle projects; Drive technical and project plan issues to closure; Manage multiple concurrent projects with minimal supervision; Define budget requirements and report financial actuals; Communicate project status to senior management.
Seniority
Senior, hands-on IC