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Associate Director Drug Product Biologics
1 month ago
• Lead drug product formulation and formulation process development in a GMP, CDMO network.
• Lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.
• Lead Drug Product PPQ.
• Lead internal and external formulation development for injectable drug products and ultimate technical transfer(s), as applicable, of the manufacturing process to commercial manufacturing site(s).
• Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project management, legal, supply chain, and other functions to meet company goals.
• Author applicable drug product sections in IND and BLA filings.
• Establish applicable technical procedures and business process flows to support drug product life-cycle management.
Requirements
- Masters degree in relevant field with about 10 years industry experience preferably with biologics.
- Regulatory filing experience with IND preferably with BLA too.
- Experience submitting authoring CMC sections for single fill syringe pharmaceuticals.
- At least 5-7 years drug product experience with biologics.
