Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations
$96,197–$144,295 year
On-siteGaithersburg, Maryland, United States
Job Summary
Lead technology transfer and process characterization for pivotal clinical manufacturing, ensuring successful commercialization of cell therapy products. Develop and execute technical frameworks for Process Performance Qualification (PPQ) readiness and oversight at global manufacturing sites. Implement proactive analysis and Continued Process Verification (CPV) strategies to maintain process control and identify improvements that enhance robustness, cost of goods, and supply continuity. Provide technical oversight across the manufacturing lifecycle, from validation to post-approval optimization, while managing regulatory risks and contributing to CMC sections of regulatory submissions. Partner with cross-functional teams including Late-Stage Process Development, Quality, and Supply Chain to ensure compliance with cGMP and ICH guidelines. Requires up to 10% domestic and international travel.
Required Qualifications
- B.S. or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline
- Ph.D. with 1+ years; OR M.S. with 5+ years, OR B.S. with 7+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas
- Background in GMP manufacturing operations and technology transfer
- Experience in process validation and CPV
- Experience in authoring CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections
- High standards of quality, accountability, and urgency — with the resilience to thrive in a fast-paced cell & gene therapy field
- up to 10% domestic and international travel
Desired Qualifications
- Advanced degree preferred
- Technical and hands-on expertise in cell therapy manufacturing processes and technologies
- Experience in viral vectors, vaccines, or biologics
- Experience in process validation and CPV desired
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