{"schemaVersion":"jobsearcher.job.v1","id":"3432e7aeb73f63dfac4b19d5","url":"https://jobsearcher.com/jobs/3432e7aeb73f63dfac4b19d5","canonicalUrl":"https://jobsearcher.com/jobs/3432e7aeb73f63dfac4b19d5","title":"Process Engineer, Process Development","description":"ResponsibilitiesLead design, optimization and technical execution of process development activities for autologous CAR T cell workflows (cell isolation, activation, transduction/transfection, expansion, harvest, formulation, cryopreservation)Develop and implement automated formulation and fill/finish processes for cell therapy drug product, including closed-system and aseptic considerationsSupport the integration and validation of robotics platforms with cell processing steps as process subject matter expertDesign experiments, run bench- and pilot-scale studies, maintain accurate lab notebook entries, analyze data, and generate technical reportsDraft and maintain process documentation including process descriptions, process control strategies, bill of materials, and standard operating proceduresMaintain accurate documentation (protocols, batch records, risk assessments, CAPAs) consistent with regulatory and GMP standardsSupport technology transfer to MSAT and manufacturing, including development of manufacturing instructions, equipment requirements, training materials, and execution supportWork with analytical development and quality control to define in-process controls, release testing, and associated acceptance criteriaSupport equipment qualification, process validation, and troubleshooting in GMP environmentsParticipate in cross-functional project teams and present technical updates to stakeholdersQualificationsBS in Chemical, Biomedical, Biological Engineering, or related field  and 8 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferredMS in Chemical, Biomedical, Biological Engineering, or related field (MS preferred) and 6 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferred.Practical experience designing and executing cell culture/expansion and formulation processes for cell therapy drug productsHands-on experience with automation of formulation and fill/finish steps; familiarity with closed-system processing and aseptic fill technologiesKnowledge of GMP requirements, technology transfer practices, and manufacturing support (MSAT)Strong data analysis skills and proficiency with experimental design, statistical analysis, and process characterizationExcellent technical writing skills for protocols, reports, and process transfer packagesExperience with specific automated platforms (e.g., CliniMACS Prodigy, CTS Rotea, CTS Compleo, GatheRex, GE WAVE, Dynaselect) or robotic solutionsExperience integrating robotics and automation systems (e.g., liquid handlers, robotic arms, automated incubators/bioreactors) into bioprocess workflowsStrong problem-solving and troubleshooting capability in laboratory and pilot-scale environmentsCollaborative team player with demonstrated ability to work cross-functionally with MSAT, manufacturing, analytical, QA, and RegCMCEffective communicator—able to present complex technical concepts clearly to scientific and non-scientific stakeholdersOrganized, detail-oriented, able to manage multiple priorities and project timelinesComfortable working in dynamic, fast-paced biotech environments","company":"Kyverna Therapeutics","rawCompany":"kyverna therapeutics","city":"Emeryville","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-05-06T08:46:59.864Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"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, Process Development","description":"ResponsibilitiesLead design, optimization and technical execution of process development activities for autologous CAR T cell workflows (cell isolation, activation, transduction/transfection, expansion, harvest, formulation, cryopreservation)Develop and implement automated formulation and fill/finish processes for cell therapy drug product, including closed-system and aseptic considerationsSupport the integration and validation of robotics platforms with cell processing steps as process subject matter expertDesign experiments, run bench- and pilot-scale studies, maintain accurate lab notebook entries, analyze data, and generate technical reportsDraft and maintain process documentation including process descriptions, process control strategies, bill of materials, and standard operating proceduresMaintain accurate documentation (protocols, batch records, risk assessments, CAPAs) consistent with regulatory and GMP standardsSupport technology transfer to MSAT and manufacturing, including development of manufacturing instructions, equipment requirements, training materials, and execution supportWork with analytical development and quality control to define in-process controls, release testing, and associated acceptance criteriaSupport equipment qualification, process validation, and troubleshooting in GMP environmentsParticipate in cross-functional project teams and present technical updates to stakeholdersQualificationsBS in Chemical, Biomedical, Biological Engineering, or related field  and 8 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferredMS in Chemical, Biomedical, Biological Engineering, or related field (MS preferred) and 6 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferred.Practical experience designing and executing cell culture/expansion and formulation processes for cell therapy drug productsHands-on experience with automation of formulation and fill/finish steps; familiarity with closed-system processing and aseptic fill technologiesKnowledge of GMP requirements, technology transfer practices, and manufacturing support (MSAT)Strong data analysis skills and proficiency with experimental design, statistical analysis, and process characterizationExcellent technical writing skills for protocols, reports, and process transfer packagesExperience with specific automated platforms (e.g., CliniMACS Prodigy, CTS Rotea, CTS Compleo, GatheRex, GE WAVE, Dynaselect) or robotic solutionsExperience integrating robotics and automation systems (e.g., liquid handlers, robotic arms, automated incubators/bioreactors) into bioprocess workflowsStrong problem-solving and troubleshooting capability in laboratory and pilot-scale environmentsCollaborative team player with demonstrated ability to work cross-functionally with MSAT, manufacturing, analytical, QA, and RegCMCEffective communicator—able to present complex technical concepts clearly to scientific and non-scientific stakeholdersOrganized, detail-oriented, able to manage multiple priorities and project timelinesComfortable working in dynamic, fast-paced biotech environments","datePosted":"2026-05-06T08:46:59.864Z","dateModified":"2026-05-06T08:46:59.864Z","hiringOrganization":{"@type":"Organization","name":"Kyverna Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Emeryville","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3432e7aeb73f63dfac4b19d5"},"url":"https://jobsearcher.com/jobs/3432e7aeb73f63dfac4b19d5"}}