AstraZeneca
– Tarzana –, CA
Shift: Full time
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 pr oducts . 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 . Key Responsibilities Site manufacturing support Manage, guide, and mentor MS T engineer (s) Process Execution Support: 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 ) Operations Support: Lead Site MS T representation at 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 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 shepherding changes through cross ‑ functional change controls 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 ; Develop and drive lessons-learned, playbooks, and best practices across sites. Regulatory 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 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 d evelopment 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 ). Cross ‑ Functional Collaboration 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 Required Qualifications Education 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 1 0 years of hands - on industry experience. Technical Skills Strong technical and ha