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 AstraZenecas Santa Monica CA and Tarzana CA locations.

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

This is a people-manager role overseeing a teamofengineers with occasional individual contributions that may include:leadingtechnical supportdeveloping technical instructionsprocedures and operator training contentperforming data analysis andprocess performance trendingleading complex deviation investigationsleadingimplementation 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 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 where)

• Operations Support:LeadSite MS&Trepresentationatoperational 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 technical investigations for deviations and process excursions perform root cause analysisdevelopand implement CAPAs withappropriate data.

• Continuous improvements:Identify justify and implement continuous improvementsby shepherding changes through crossfunctional 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;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;Developand drivelessons-learned playbooks and best practices across sites.

• Regulatory Contributions: Draft and review CMC sections (Module 3) response to agencyquestionsupport 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-outengineering runs PPQ batches and commercial manufacturing campaigns (including off-shift support when).

CrossFunctional 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 processesincludingcontinuous 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 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-functional leadership 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

When we put unexpected teams in the same room we unleash bold thinking with the power to encourage life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 $142377.60 - $213566.40. 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 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 tableFantastic! We have one seat available and we hope its 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.