Associate Director / Director - Biologics Drug Product Development
Core
Strategic and technical oversight for drug product formulation, process development, and technology transfer for biologics and genetic medicines.
Role type
Senior IC Director / Associate Director (Biologics Drug Product Development)
Builds
Ultra-high concentration drug product formulations and processes for biologics modalities
Domain
Biopharmaceuticals / Biologics / Genetic Medicine
Required skills
Biologics drug product development, Ultra-high concentration formulation, Sterile manufacturing unit operations, Regulatory filings authoring, Cross-functional team leadership, People management (5+ years)
Preferred skills
Fixed dose combinations, Drug product-device integration, Third-party manufacturer management, Quality risk management
Technologies
None explicitly listed
Responsibilities
Provide strategic oversight for formulation and process development, Oversee portfolio of 5-7 pipeline programs, Author technical reports and regulatory filings, Supervise and mentor a team of 8-10 scientists, Serve as subject matter expert for due diligence
Seniority
Director / Associate Director, Senior Leadership
