Associate Director, Drug Substance MSAT
On-siteHolly Springs, North Carolina, United States
Job Summary
Lead end-to-end process stewardship for assigned upstream and downstream manufacturing suites, directing technical strategy from new product introduction through commercialization. Execute tech transfer, process performance qualification, and continuous improvement initiatives while maintaining current process control strategies and documentation. Manage team performance, oversee critical manufacturing investigations, and author Chemistry, Manufacturing, and Control sections for regulatory filings. Collaborate cross-functionally with Manufacturing, Quality, and Engineering to ensure compliant, on-time drug substance delivery. Requires Master's degree with 9+ years of experience or Bachelor's with 11+ years, plus 8+ years in people management and 9+ years in CMC leading pre-approval activities. Based in Holly Springs, North Carolina, this role supports Fujifilm Biotechnologies' expansion of its end-to-end CDMO facility.
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
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