Manufacturing Science and Technology
On-site · Malvern, Pennsylvania, United States
Job Summary
Director, Manufacturing Science & Technology (MS&T) provides strategic leadership for GMP manufacturing across internal and external operations, overseeing technology transfer, process validation (PPQ), and CPV; serves as a liaison between Process Development, Manufacturing, Quality, and Regulatory Affairs; drives lifecycle management, BLA readiness, and continuous process improvement; requires a Bachelor's or advanced degree in Chemical/Biochemical Engineering or related life sciences and 12+ years in biologics/vaccines/cell and gene therapy manufacturing with 5+ years in leadership; position based in Malvern, PA with in-office work.
Required Qualifications
- Bachelor’s or advanced degree (M.S./Ph.D.) in Chemical Engineering, Biochemical Engineering, or related life sciences discipline
- 12+ years of experience in biologics, vaccines, or cell and gene therapy manufacturing
- at least 5 years in a leadership role within MS&T, Technical Operations, or Process Validation
- Proven success leading tech transfer, process validation, and CPV in GMP-regulated environments
- Strong understanding of process design, process validation lifecycle, control strategy, and GMP manufacturing science
- Experience supporting regulatory filings (IND, BLA, MAA) and responding to agency questions
- Demonstrated ability to translate strategy into operational plans and results
- Exceptional collaboration and influencing skills across cross-functional and external teams
- Strong organizational and problem-solving capability, able to manage ambiguity and competing priorities
- Commitment to Ocugen’s values of Integrity, Teamwork, Respect, and Accountability
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