Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
$142,378–$213,566 year
On-site · Santa Monica, California, United States
Job Summary
Principal Process Engineer lead for MS&T in cell therapy manufacturing, providing site manufacturing support across CA facilities (Santa Monica and Tarzana). Responsible for on-the-floor technical support during critical campaigns, mentoring MS&T engineers, leading deviation investigations and CAPAs, driving technology transfer and process validation/PPQ, and contributing to regulatory deliverables. Role includes batch-record review/execution, data trending and control-chart analysis, cross-functional change controls with risk assessments, qualification of critical materials, documentation and GMP compliance, operator training, and collaboration with Regulatory for CMC inputs and audits. Requires hands-on cell therapy unit operations experience in GMP environments, strong data analysis and technical writing, and leadership across site-wide MS&T activities. On-site in CA with ~15% travel to other facilities; office-based environment with flexible working expectations.
Required Qualifications
- PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 4+ years of industry experience; OR MS in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of industry experience OR BS with 10+ years of hands-on industry experience.
Additional Requirements
- None specified in posting
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