Manager / Senior Manager, Technical Operations
Core
Lead Technical Operations programs to support the development and commercial supply of neffy™, a needle-free epinephrine product.
Role type
Senior Manager, Technical Operations
Builds
Reliable supply of FDA-approved pharmaceutical products
Domain
Pharmaceutical manufacturing and supply chain
Required skills
cGMP knowledge, project management, vendor/CMO management, formulation and process development, technology transfer, process validation, root-cause analysis, regulatory CMC support, serialization/DSCSA compliance, clinical supply coordination
Preferred skills
Advanced degree, experience with drug-device combination products, sterile manufacturing, commercial product launch, 3PL operations, IRT/IWRS activities
Technologies
Microsoft Office, project management tools, EPCIS systems
Responsibilities
Manage cross-functional Technical Operations projects and external partner interactions; oversee formulation, scale-up, and technology transfer; plan clinical and commercial manufacturing campaigns; review manufacturing documentation and resolve deviations; support vendor selection and qualification; monitor process performance and drive continuous improvement; support regulatory submissions and commercial supply operations including serialization and clinical supply.
Seniority
Senior, hands-on IC with management responsibilities