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 AstraZenecasSanta 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 supportdeveloping technical instructionsprocedures and operator training contentperforming data analysis andprocess performance trendingsupportingdeviation investigationsdrivingimplementation of CAPAs andcontinuous improvementthrough change controls andcontributing to validation and regulatory deliverables.These responsibilities will beexercisedthroughthe scope of supportingtechnology transferclinical manufacturing site readinessprocess 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 where)

• Operations Support:Represent Site MS&T functionat siteoperational tiermeetingsprovidingcollaborative inputsthat drive site activities

• Datatrending and analysis:Maintainmanufacturingdata tracking system and control charts perform trend analysesidentifysignals 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 analysisdevelopand implement CAPAs withappropriate data.

• Continuous improvements:Identify justify and implement continuous improvementsbyshepherdingchanges through crossfunctional 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;protocolsmanufacturing summary reportsensure 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 questionsupport 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 onthefloor technical support during scaleup engineering runs PPQ batches and commercial manufacturing campaigns (including offshift support when).

CrossFunctional 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 processesincludingcontinuous 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. with3 years of handson 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 univariatemulti-variateanalysiscontrol charts)

• Demonstrated abilityinaccurateand thoroughtechnical writing paired withclear and concise verbal communication

• Strong data analysis and problemsolving skills.

Soft skills

• Excellent crossfunctional 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 latestageclinical 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