Related skills
supply chain manufacturing regulatory scale-up cgmp๐ Description
- Provide strategic leadership of external manufacturing across clinical and commercial supply
- Establish CDMO partnerships to ensure strong performance and program alignment
- Define manufacturing strategies for tech transfer, scale-up, and lifecycle management
- Establish supplier performance metrics and business review processes
- Mentor and build a team of supplier relationship owners
- Ensure supply continuity through proactive risk identification, mitigation and escalation
๐ฏ Requirements
- Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred
- ~15+ years of pharma/biotech manufacturing experience, including external leadership
- Proven track record managing CDMOs across clinical and commercial supply environments
- Deep understanding of cGMP regulations, global manufacturing requirements, and regulatory expectations
- Experience in manufacturing strategy, technology transfer, and commercialization activities
- Demonstrated ability to lead in complex, multi-program environments and drive cross-functional alignment
๐ Benefits
- Remote work opportunities within the United States
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