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Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

AstraZeneca · Santa Monica, CA

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FULL-TIME Posted Sep 21, 2026 103,286.40–154,929.60 a year

Job Description

## Join the Cell Therapy Revolution as a Senior Process Engineer

At Astra. Zeneca, we’re dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Our Cell Therapy Development and Operations team is looking for a Senior Process Engineer to ensure robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products. This position, reporting to the Director of MS&T, Cell Therapy Development and Operations, is based onsite in Tarzana, CA.

### What You’ll Do

You will provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns, and occasional off-shift support. Represent the Site MS&T function at operational tier meetings, providing collaborative inputs that drive site activities. Maintain manufacturing data tracking systems and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment. Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, and develop and implement CAPAs. Identify, justify, and implement continuous improvements by shepherding changes through cross-functional change controls with appropriate risk assessments and comparability. Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies), assess impact of raw material changes, and contribute to second-source strategies. Partner with automation and digital manufacturing teams to implement electronic batch record improvements. Author and revise batch records, SOPs, technical reports, protocols, and summary reports, ensuring adherence to c. GMP/ATMP requirements and data integrity principles (ALCOA+). Deliver operator training on critical process steps or process changes, and contribute to lessons-learned, playbooks, and best practices across sites. Draft and review CMC sections (Module 3) for regulatory responses and support health authority and internal audits and inspections.

You will also contribute to technology transfer and process validation by drafting and reviewing risk assessments and comparability study designs, contributing to technology transfer packages, implementing process changes, coordinating engineering runs and comparability/bridging studies, and authoring technical reports. Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols and reports. Provide on-the-floor technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns, including off-shift support when required.

Your role will serve as the primary interface between site Manufacturing, Quality, Supply Chain, and global functions of Process Development and CMC regulatory. You will support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes.

### Qualifications We’re Looking For
• *Education** – Ph. D in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 5+ years of hands-on industry experience; OR B.S. with 8+ years of hands-on industry experience.
• *Technical Skills** – Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment. Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations. Proficiency with statistical analysis, including univariate and multivariate analysis and control charts. Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication. Strong data analysis and problem-solving skills.
• *Soft Skills** – Excellent cross-functional communication and collaboration. Ability to translate complex data into clear decisions and regulatory-ready narratives. Excellent problem solving, cross-functional leadership, and communication under time-sensitive conditions.
• *Preferred Qualifications** – Experience with late-stage clinical manufacturing support of cell therapy products. Experience with process validation and commercial readiness of cell therapy products.

### Work Environment

This is an onsite role in Tarzana, CA. You must be willing to travel approximately 15% to other manufacturing facilities and be part of an on-call rotation during engineering runs, PPQ, and critical campaigns.

### Compensation & Benefits

The annual base pay for this position ranges from $103,286.40 to $154,929.60. Our positions offer eligibility for short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), plus health, dental, and vision coverage in accordance with the terms of the applicable plans. Date posted 17-Sep-2026, closing date 08-Oct-2026.

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Benefits

  • Health insurance
  • Paid time off
  • Dental insurance

Additional Details

City
Santa Monica
State
California
Country
US
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