Director / Senior Director, Technical Operations
Core
Strategic leadership for external manufacturing and Technical Operations supporting the development, lifecycle management, and commercial supply of neffy™ (needle-free epinephrine).
Role type
Senior Director, Technical Operations (Pharmaceutical Manufacturing)
Builds
Scalable outsourced manufacturing network, commercial supply chain, and clinical supply operations for neffy™
Domain
Pharmaceutical manufacturing / Biotechnology / CDMO management
Required skills
cGMP knowledge, CMO/CDMO management, process validation, technology transfer, lifecycle management, cross-functional leadership, budget management, risk assessment, regulatory alignment (CMC), supply chain strategy, serialization/DSCSA compliance, clinical supply operations
Preferred skills
Advanced degree (MS, PhD, or MBA), experience with 3PL management, EPCIS data exchange, IRT/IWRS coordination
Technologies
Microsoft Office, project management tools, data-management tools, Interactive Response Technology (IRT), Interactive Web Response System (IWRS)
Responsibilities
Establish manufacturing strategy and priorities for outsourced network; oversee CMO/CDMO performance and governance; lead formulation, scale-up, and process validation; manage commercial and clinical supply operations; ensure DSCSA compliance and serialization; partner with Regulatory Affairs on CMC strategy; lead business planning and budget development; resolve major technical and supply issues.
Seniority
Senior Director, strategic leadership & cross-functional influence