Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

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 role will oversee a team   of   engineers, with 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 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