Associate Director Drug Product Biologics

Major Duties/Responsibilities

· 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.