VP of Manufacturing and Supply

Job Opportunity: VP, Head of Manufacturing and Supply

Our cutting-edge biotech partner based in the San Francisco Bay Area is seeking an exceptional VP, Head of Supply to spearhead late-stage CMC activities and drive the commercial launch of large molecule programs. This is a strategic, executive role in a streamlined, virtual organization with a global CDMO network. The company specializes in rare metabolic diseases and has an experienced leadership team. This high-level position is expected to be filled quickly.

Key Responsibilities:

• Oversee clinical and commercial manufacturing, encompassing CMC, process development, and supply chain management.
• Transition the existing CMC function to support global commercial manufacturing and supply chain operations.
• Collaborate with external vendors, research teams, clinical development, operations, regulatory, and business units on early and late-stage pipeline development.
• Develop and execute CMC regulatory submission strategies worldwide.

Required Qualifications:

• A minimum of a BS, with a preference for a PhD in a relevant field, and at least 10 years of experience in CMC, manufacturing, supply chain, and process development.
• Demonstrated expertise in biologics development, particularly antibodies.
• Proven experience in establishing and managing global commercial product supply chains and success in CMC regulatory filings for INDs and BLAs.