{"schemaVersion":"jobsearcher.job.v1","id":"f9e8ed6d7e0c13f7d080b2e9","url":"https://jobsearcher.com/jobs/f9e8ed6d7e0c13f7d080b2e9","canonicalUrl":"https://jobsearcher.com/jobs/f9e8ed6d7e0c13f7d080b2e9","title":"Process Engineer, Cell Therapy Process Development","description":"OverviewIn this role you will advance late-stage cell therapy process development, characterization, and BLA-enabling studies. You will work on cell therapy unit operations with both semi-automated and fully automated equipment, driving scalable, compliant processes. You'll design and analyze experiments, support tech transfer and manufacturing readiness, and apply digital tools to accelerate insights. This is an impact-driven position that spans development to commercial readiness within a fast-paced, cross-functional environment.Compensation / Benefitsqualified retirement programspaid time off (vacation, holiday, leaves)health, dental, and vision coverageincentives and short-term incentive bonusesequity-based awards for salaried rolescommissions for sales rolesResponsibilitiesDesign and optimize autologous/allogeneic cell therapy processes for robustnessImplement closed-system operations and automation for scale-upPlan and execute DOE/multivariate studies and scale-down/up assessments per QbD/ICHAnalyze data, prepare technical reports, present results to cross-functional teamsPerform batch record review, deviations, and data trending to ensure robustnessApply AI and digital analytics to accelerate data review and process understandingProvide on-the-floor technical support during scale-up, engineering runs, PPQ, and campaignsSupport raw material risk assessments, comparability studies, and cross-facility risk evaluationsCollaborate with analytical sciences and manufacturing science teams for end-to-end alignmentSupport lifecycle management, post-approval changes, and continuous improvement initiativesKey requirementsMS in relevant field with 2+ years industry experience or BS with 7+ years industry experienceStrong expertise in cell therapy unit operations (isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologicsGMP experience and familiarity with late-stage/commercial readinessAbility to analyze complex datasets and communicate recommendations across levelsExperience with late-stage development and process characterization for cell therapyProficiency in applying AI tools and digital solutions to data analysis and automationGMP batch record execution or review, deviations and investigationsStrong technical writing, data analysis, and problem-solving skillsExcellent cross-functional communicationCollaborative mindset and teamworkAbility to operate in fast-paced, late-stage environmentsAutomation platforms familiarity (CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors)DOE and multivariate data analysisExperience with JMP or similar tools","company":"AstraZeneca","rawCompany":"astrazeneca","city":"Silver Spring","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-10-26T13:22:24.990Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer, Cell Therapy Process Development","description":"OverviewIn this role you will advance late-stage cell therapy process development, characterization, and BLA-enabling studies. You will work on cell therapy unit operations with both semi-automated and fully automated equipment, driving scalable, compliant processes. You'll design and analyze experiments, support tech transfer and manufacturing readiness, and apply digital tools to accelerate insights. This is an impact-driven position that spans development to commercial readiness within a fast-paced, cross-functional environment.Compensation / Benefitsqualified retirement programspaid time off (vacation, holiday, leaves)health, dental, and vision coverageincentives and short-term incentive bonusesequity-based awards for salaried rolescommissions for sales rolesResponsibilitiesDesign and optimize autologous/allogeneic cell therapy processes for robustnessImplement closed-system operations and automation for scale-upPlan and execute DOE/multivariate studies and scale-down/up assessments per QbD/ICHAnalyze data, prepare technical reports, present results to cross-functional teamsPerform batch record review, deviations, and data trending to ensure robustnessApply AI and digital analytics to accelerate data review and process understandingProvide on-the-floor technical support during scale-up, engineering runs, PPQ, and campaignsSupport raw material risk assessments, comparability studies, and cross-facility risk evaluationsCollaborate with analytical sciences and manufacturing science teams for end-to-end alignmentSupport lifecycle management, post-approval changes, and continuous improvement initiativesKey requirementsMS in relevant field with 2+ years industry experience or BS with 7+ years industry experienceStrong expertise in cell therapy unit operations (isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologicsGMP experience and familiarity with late-stage/commercial readinessAbility to analyze complex datasets and communicate recommendations across levelsExperience with late-stage development and process characterization for cell therapyProficiency in applying AI tools and digital solutions to data analysis and automationGMP batch record execution or review, deviations and investigationsStrong technical writing, data analysis, and problem-solving skillsExcellent cross-functional communicationCollaborative mindset and teamworkAbility to operate in fast-paced, late-stage environmentsAutomation platforms familiarity (CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors)DOE and multivariate data analysisExperience with JMP or similar tools","datePosted":"2026-10-26T13:22:24.990Z","dateModified":"2026-10-26T13:22:24.990Z","hiringOrganization":{"@type":"Organization","name":"AstraZeneca","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Silver Spring","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f9e8ed6d7e0c13f7d080b2e9"},"url":"https://jobsearcher.com/jobs/f9e8ed6d7e0c13f7d080b2e9"}}