Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

We are seekingan experiencedProcess 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 facilitiesat AstraZeneca’sSanta Monica, CA and Tarzana, CA locations. Requires up to 15% travel, both domestic and international.

This position focuses onensuring robust, compliant, and cost-effective manufacturing ofclinical and commercialcell therapy products.

Responsibilities includesupportingon-the-floor/ hands-ontechnical support,developing technical instructions,procedures, and operator training content,performing data analysis andprocess performance trending,supportingdeviation investigations,drivingimplementation 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 totheAssociateDirector, MS&T, CellTherapyDevelopmentand Operations.

Key Responsibilities

Site manufacturing support

• Process Execution Support: Provide day-to-day technical support forcell therapy manufacturing, including on-the-floor support for critical campaigns(includingoccasionaloff-shift support whererequired)

• Operations Support:Represent Site MS&T functionat siteoperational 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 or co-lead technical investigations for deviations and process excursions, perform root cause analysis,developand implement CAPAs withappropriate data.

• Continuous improvements:Identify, justify, and implement continuous improvementsbyshepherdingchanges through cross‑functional change controlswithappropriate 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; contribute to lessons-learned, playbooks, and best practices across sites.

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

Technology Transfer & Process Validation

• Draft and reviewrisk assessmentsandcomparability study 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

• Translateprocess characterizationoutputs fromdevelopment 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 whenrequired).

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 managementfor cell therapy processes,includingcontinuous improvement initiativesand post-approval changes 

Required Qualifications

Education

• 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 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-functionalpartnership, 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