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Astrazeneca2 weeks ago

Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

$142,378–$213,566 year

On-site · Santa Monica, California, United States

Type
Full Time
Level
Senior Level
Education
Doctorate Or Professional Degree
Company size
Enterprise

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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$142k – $214k / yr

Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy · Astrazeneca

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