Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

AstraZeneca•Santa Monica, CA

2d•Onsite

About The Position

We are seeking an experienced Principal Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team. This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products. This is a people-manager role overseeing a team of engineers, with occasional individual contributions that may include: leading technical support, developing technical instructions, procedures, and operator training content, performing data analysis and process performance trending, leading complex deviation investigations, leading implementation of CAPAs and continuous improvement through change controls, and contributing to validation and regulatory deliverables. These responsibilities will be exercised through the scope of supporting, technology transfer, clinical manufacturing, site readiness, process validation/PPQ, commercial manufacture readiness, and product lifecycle management activities. The ideal candidate brings hands-on experience with cell therapy unit operations through previous experience in process development and/or manufacturing, as well as expertise in technology transfer. Experience with process validation and commercialization activities is desired. This position will report to the Associate Director, MS&T, Cell Therapy Development and Operations.

Requirements

PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 4+ years of industry experience; OR M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of industry experience OR B.S. with 10+ years of hands-on industry experience.
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, multi-variate analysis, control charts)
Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication
Strong data analysis, and problem‑solving 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.

Nice To Haves

Experience with late‑stage clinical manufacturing support of cell therapy products
Experience with process validation and commercial readiness of cell therapy products

Responsibilities

Manage, guide, and mentor MS&T engineer(s)
Provide day-to-day technical support for cell therapy manufacturing, including managing on-the-floor support for critical campaigns (including occasional off-shift support where required)
Lead Site MS&T representation at operational tier meetings, providing collaborative inputs that drive site activities
Maintain manufacturing data tracking system 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 technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data.
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) and assess impact of raw material changes, and contribute to second-source strategies
Author and revise batch records, SOPs, and technical reports; protocols, manufacturing summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
Deliver operator training on critical process steps or process changes; Develop and drive lessons-learned, playbooks, and best practices across sites.
Draft and review CMC sections (Module 3), response to agency question, support health authority and internal audits/inspections.
Draft and review risk assessments and comparability study design
Establish framework for New Product Introduction procedures and intake at the site
Lead technology transfer activities (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports
Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports
Provide and manage on the floor technical support during scale-out, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off-shift support when required).
Serve as site MS&T lead at CMC and functional governance meetings
Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory
Support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes

Benefits

short-term incentive bonus opportunity
equity-based long-term incentive program (salaried roles)
retirement contribution (hourly roles)
commission payment eligibility (sales roles)
qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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