{"schemaVersion":"jobsearcher.job.v1","id":"8c79f429df05d1a91ed1c14f","url":"https://jobsearcher.com/jobs/8c79f429df05d1a91ed1c14f","canonicalUrl":"https://jobsearcher.com/jobs/8c79f429df05d1a91ed1c14f","title":"Process Engineer, Upstream Process Characterization & Commercialization","description":"We are seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. In this role, you will contribute to late-stage development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to internal and external manufacturing sites.\n\nThis position focuses specifically on upstream unit operations, including shake flask and bioreactor-based cell culture, transient transfection, cell expansion, harvest operations, and scale‑up across development and commercial platforms (including Amber systems).\n\nThe ideal candidate has strong hands‑on experience in upstream viral vector manufacturing, transient transfection-based processes, and can provide on‑the‑floor technical leadership during engineering, PPQ, and commercial campaigns.\nKey Responsibilities\nUpstream Process Characterization & Validation\nDesign, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments).\nDevelop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations.\nPerform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums.\nSupport development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters.\nConduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes.\nApply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.\nPPQ, Tech Transfer & Manufacturing Readiness\nContribute to PPQ planning, readiness, execution, and documentation for upstream processes.\nSupport technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation.\nProvide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).\nSupport raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.\nRegulatory Support\nContribute to authoring and review of CMC documentation, including upstream process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.\nSupport preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing.\nCross‑Functional Collaboration\nWork closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.\nRepresent upstream characterization activities in technical meetings, reviews, and governance discussions.\nSupport lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes.\nRequired Qualifications\nPh.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience.\nHands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes.\nExperience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred.\nExperience with late‑stage development, process characterization, and PPQ principles for upstream processes.\nDemonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.\nExperience working in GMP environments, including batch record execution or review, deviations, and investigations.\nStrong technical writing, data analysis, and problem‑solving skills.\nPreferred Qualifications\nExperience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs).\nExperience designing and executing DOE and multivariate data analysis for upstream processes.\nExperience contributing to BLA/MAA submissions or regulatory interactions.\nKnowledge of control strategy development and risk assessment tools (e.g., FMEA).\nFormal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.\nKey Competencies\nStrong experimental design and execution skills.\nExcellent cross‑functional communication and collaboration.\nAbility to operate effectively in fast‑paced, late‑stage development environments.\nScientific curiosity, ownership mindset, and willingness to support manufacturing operations.\nThe annual base pay for this position ranges from $76,308.00 - $114,462.00. 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 experience. In 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.","company":"AstraZeneca","rawCompany":"astrazeneca","city":"Gaithersburg","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:46:32.676Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer, Upstream Process Characterization & Commercialization","description":"We are seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. In this role, you will contribute to late-stage development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to internal and external manufacturing sites.\n\nThis position focuses specifically on upstream unit operations, including shake flask and bioreactor-based cell culture, transient transfection, cell expansion, harvest operations, and scale‑up across development and commercial platforms (including Amber systems).\n\nThe ideal candidate has strong hands‑on experience in upstream viral vector manufacturing, transient transfection-based processes, and can provide on‑the‑floor technical leadership during engineering, PPQ, and commercial campaigns.\nKey Responsibilities\nUpstream Process Characterization & Validation\nDesign, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments).\nDevelop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations.\nPerform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums.\nSupport development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters.\nConduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes.\nApply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.\nPPQ, Tech Transfer & Manufacturing Readiness\nContribute to PPQ planning, readiness, execution, and documentation for upstream processes.\nSupport technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation.\nProvide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).\nSupport raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.\nRegulatory Support\nContribute to authoring and review of CMC documentation, including upstream process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.\nSupport preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing.\nCross‑Functional Collaboration\nWork closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.\nRepresent upstream characterization activities in technical meetings, reviews, and governance discussions.\nSupport lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes.\nRequired Qualifications\nPh.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience.\nHands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes.\nExperience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred.\nExperience with late‑stage development, process characterization, and PPQ principles for upstream processes.\nDemonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.\nExperience working in GMP environments, including batch record execution or review, deviations, and investigations.\nStrong technical writing, data analysis, and problem‑solving skills.\nPreferred Qualifications\nExperience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs).\nExperience designing and executing DOE and multivariate data analysis for upstream processes.\nExperience contributing to BLA/MAA submissions or regulatory interactions.\nKnowledge of control strategy development and risk assessment tools (e.g., FMEA).\nFormal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.\nKey Competencies\nStrong experimental design and execution skills.\nExcellent cross‑functional communication and collaboration.\nAbility to operate effectively in fast‑paced, late‑stage development environments.\nScientific curiosity, ownership mindset, and willingness to support manufacturing operations.\nThe annual base pay for this position ranges from $76,308.00 - $114,462.00. 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 experience. In 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.","datePosted":"2026-04-14T10:46:32.676Z","dateModified":"2026-04-14T10:46:32.676Z","hiringOrganization":{"@type":"Organization","name":"AstraZeneca","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gaithersburg","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8c79f429df05d1a91ed1c14f"},"url":"https://jobsearcher.com/jobs/8c79f429df05d1a91ed1c14f"}}