Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
About The Position
We are seeking an experienced 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 location s . Requires up to 15% travel, both domestic and international. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy pr oducts . Responsibilities include supporting on-the-floor / hands-on technical support, developing technical instructions , procedures , and operator training content , performing data analysis and process performance trending, supporting deviation investigations, d riving 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
- Process engineer: M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR B.S. with 3 + 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 e xperience 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 d ata 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 partnership , and communication under time-sensitive conditions.
Nice To Haves
- Experience with l ate ‑ stage clinical manufacturing support of cell therapy products
- Experience with process validation and commercial readiness of cell therapy products
Responsibilities
- Site manufacturing support
- Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing , including on-the-floor support for critical campaigns (including occasional off-shift support where )
- Operations Support: Represent Site MS&T function at site operational tier meetings , pr oviding collaborative inputs that drive site activities
- Data trending and analysis : M aintain 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.
- Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
- Deviation/CAPA Support: Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data .
- Continuous improvements: Identify , justify, and implement continuous improvements by shepherd ing changes through cross ‑ functional change control s with appropriate risk assessments and comparability.
- Raw material s : 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
- Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, manufacturing summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
- Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes ; contribute to lessons-learned, playbooks, and best practices across sites.
- Regula tory Contributions: Draft and review CMC sections (Module 3), response to agency question , support health authority and internal audits/inspections.
- Technology Transfer & Process Validation
- Draft and review r isk assessments and comparability stud y design
- Contribute to technology transfer packages (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 d evelopment into manufacturing controls, and draft sections of PPQ protocols/reports
- Provide on ‑ the ‑ floor technical support during scale ‑ up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off ‑ shift support when ).
- Cross ‑ Functional Collaboration
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
