Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

We areseekingan experiencedPrincipalProcess Engineer tojoin our Manufacturing Sciences & Technology (MS&T)functionas 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 onensuring robust, compliant, and cost-effective manufacturing ofclinical and commercialcell therapy products.

This role will oversee a teamofengineers, with individual contributions that may include:leadingtechnical support,developing technical instructions,procedures, and operator training content,performing data analysis andprocess performance trending,leading complex deviation investigations,leadingimplementation of CAPAs andcontinuous improvementthrough change controls, andcontributing to validation and regulatory deliverables.These responsibilities will beexercisedthroughthe scope of supporting,technology transfer,clinical manufacturing, site readiness,process validation/PPQ, commercialmanufacturereadiness, andproductlifecycle managementactivities.

The ideal candidate bringshands-on experience with cell therapy unit operations throughpreviousexperience in process development and/or manufacturing, as well asexpertiseintechnology transfer. Experience withprocess validationand commercialization activitiesis desired. This position will report tothe AssociateDirector, MS&T, Cell TherapyDevelopmentand 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, includingmanagingon-the-floor support for critical campaigns(including occasional off-shift support whererequired)

• Operations Support:LeadSite MS&Trepresentationatoperational tiermeetings,providingcollaborative inputsthat drive site activities

• Datatrending and analysis:Maintainmanufacturingdata tracking system and control charts, perform trend analyses,identifysignals, and drivetimelysignal-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,developand implement CAPAs withappropriate data.

• Continuous improvements:Identify, justify, and implement continuous improvementsby shepherding changes through cross-functional change controls withappropriate riskassessments and comparability.

• Rawmaterials: Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact ofraw material changes, andcontribute 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 oncritical process steps or process changes;Developand drivelessons-learned, playbooks, and best practices across sites.

• Regulatory Contributions: Draft and review CMC sections (Module 3), response to agencyquestion,support healthauthorityand internal audits/inspections.

Technology Transfer & Process Validation

• Draft and reviewrisk assessmentsandcomparability study design

• Establish framework for New Product Introductionprocedures and intake at the site

• Leadtechnology transferactivities(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 fromdevelopment into manufacturing controls, and draft sections of PPQ protocols/reports

• Provideand manageonthefloor technical support duringscale-out,engineering runs, PPQ batches, and commercial manufacturing campaigns (including off-shift support whenrequired).

Cross -Functional Collaboration

• Serve as site MS&T leadat 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 managementfor cell therapy processes,includingcontinuous improvement initiativesand post-approval changes

Required Qualifications

Education

• PhDin Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with4+ years of industryexperience;

• ORM.S.in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with8+ years of industry experience

• OR B.S. with10+ years of hands-on industry experience.

Technical Skills

• Strong technicaland hands-onexpertisein key cell therapy unit operationsand common cell therapy processing equipment

• Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations.

• Proficiencywith statistical analysis(including univariate,multi-variateanalysis,control charts)

• Demonstrated abilityinaccurateand thoroughtechnical writing, paired withclear and concise verbal communication

• Strong data 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 late-stageclinical manufacturing support of cell therapy products

• Experience with process validation andcommercial readinessof cell therapy products

Work Environment

• On-site inSanta Monica and Tarzana, CA

• Ability to travel ~15% 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

Closing Date

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.