Associate Director, Drug Substance MSAT
On-siteHolly Springs, North Carolina, United States
Job Summary
Lead end-to-end process stewardship for an assigned manufacturing suite, directing upstream and downstream technical leads for tech transfer execution and readiness. Own product and process strategy from new product introduction through commercialization, translating critical quality attributes into control plans while ensuring floor presence, safety, and compliance. Drive continuous improvement projects to enhance manufacturability, reliability, and efficiency, and oversee critical investigations, deviations, and corrective actions. Author CMC sections for regulatory filings and coordinate cross-functional delivery with Manufacturing, Quality, and Engineering under tiered governance. This role supports Fujifilm Biotechnologies' mission to build North America's largest end-to-end CDMO facility in Holly Springs, North Carolina, delivering the next vaccine, cure, or therapy.
Required Qualifications
- Master's degree in an Engineering or Scientific field
- Bachelor's degree in an Engineering or Scientific field
- 9+ years of experience
- 11+ years of experience
- 8+ years of people management/leadership experience
- 9+ years of CMC experience leading pre-approval and post-approval activities for biologic product
- Experience with Good Manufacturing Practices (GMP)
Desired Qualifications
- 12+ years of experience in similar role with large projects from conceptual design phase to operations
- 8+ years of experience leading technical departments
- Technical leadership experience with drug substance manufacturing facilities
- Prior drug substance development and manufacturing experience including process validation, process transfer, commercialization, manufacturing support, and troubleshooting drug substance operations
- Experience communicating and collaborating with a global team
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.