Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy — San Francisco

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 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 l ate ‑ stage   clinical manufacturing support of cell therapy products   • Experience with process validation and   commercial readiness   of cell therapy products   Work Environment   • On-site in   Santa Monica and Tarzana, CA   • Ability to travel ~ 1 5 % to other manufacturing facilities    • On-call rotation during engineering/PPQ/critical campaigns   When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay for this position ranges from $ 142,377.60 - $213,566.40 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Are you ready to bring new insights and fresh thinking to the table?  Fantastic! We have one seat available, and we hope it’s yours. Apply today. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Date Posted 17-Sep-2026 Closing Date 08-Oct-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.