{"version":"0.1","company":{"name":"YubHub","url":"https://yubhub.co","jobsUrl":"https://yubhub.co/jobs/skill/process-characterization"},"x-facet":{"type":"skill","slug":"process-characterization","display":"Process Characterization","count":1},"x-feed-size-limit":100,"x-feed-sort":"enriched_at desc","x-feed-notice":"This feed contains at most 100 jobs (the most recently enriched). For the full corpus, use the paginated /stats/by-facet endpoint or /search.","x-generator":"yubhub-xml-generator","x-rights":"Free to redistribute with attribution: \"Data by YubHub (https://yubhub.co)\"","x-schema":"Each entry in `jobs` follows https://schema.org/JobPosting. YubHub-native raw fields carry `x-` prefix.","jobs":[{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_4ee3aa8d-ab3"},"title":"Senior Scientist, Viral Vector Process Development, Upstream","description":"<p>We are looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Upstream) to join our team. As a key member of our Cell Therapy modalities portfolio, you will play a critical role in building and leading a high-performing team that accelerates AstraZeneca&#39;s emerging Cell Therapy modalities portfolio.</p>\n<p>Your primary focus will be on designing, executing, and optimizing upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs.</p>\n<p>Key Responsibilities:</p>\n<ul>\n<li>Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, quality, robustness, and cost.</li>\n</ul>\n<ul>\n<li>Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.</li>\n</ul>\n<ul>\n<li>Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit for-purpose knowledge records.</li>\n</ul>\n<ul>\n<li>Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions.</li>\n</ul>\n<ul>\n<li>Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.</li>\n</ul>\n<ul>\n<li>Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.</li>\n</ul>\n<ul>\n<li>Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time, right first time) and recommend improvements.</li>\n</ul>\n<p>Qualifications:</p>\n<ul>\n<li>Education: Ph.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.</li>\n</ul>\n<ul>\n<li>Experience: Hand-on experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.</li>\n</ul>\n<ul>\n<li>Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single-use rocking-platform and stirred-tank bioreactors, and upstream-harvest interfaces; working knowledge of statistical DOE and data analytics tools.</li>\n</ul>\n<ul>\n<li>GMP Readiness: Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.</li>\n</ul>\n<ul>\n<li>Communication &amp; Teamwork: Strong written and verbal communication skills; ability to work effectively in cross-functional, matrixed teams; demonstrated problemsolving and troubleshooting capability.</li>\n</ul>\n<ul>\n<li>Tools &amp; Automation: Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.</li>\n</ul>\n<p>Preferred Qualifications:</p>\n<ul>\n<li>Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.</li>\n</ul>\n<ul>\n<li>Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.</li>\n</ul>\n<ul>\n<li>Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.</li>\n</ul>\n<ul>\n<li>Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.</li>\n</ul>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_4ee3aa8d-ab3","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Viral Vector and New Modalities Cell Therapy Operations","sameAs":"https://astrazeneca.eightfold.ai","logo":"https://logos.yubhub.co/astrazeneca.eightfold.ai.png"},"x-apply-url":"https://astrazeneca.eightfold.ai/careers/job/563877689868523","x-work-arrangement":"onsite","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":"$108,473.60 - $162,710.40","x-skills-required":["viral vector process development","upstream process development","Lentiviral Vector (LVV)","suspension bioreactor platforms","experimental design","process characterization","scale-up/tech transfer","Research","Analytical Development","CMC","Regulatory","Manufacturing","Quality","external CDMOs","Lean practices","digital tools","scheduling","data integrity","reproducibility","KPIs","titer","infectivity","impurity profiles","cycle time","right first time"],"x-skills-preferred":["single-use systems","process automation/PAT","digital lab systems (ELN/LIMS)","statistical DOE","data analytics tools","cGMP interfaces","change control","sampling plans","CMC sections","technical responses","Lean/continuous improvement","robust documentation/knowledge management"],"datePosted":"2026-04-18T22:13:28.024Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Gaithersburg, Maryland, United States of America"}},"employmentType":"FULL_TIME","occupationalCategory":"Engineering","industry":"Healthcare","skills":"viral vector process development, upstream process development, Lentiviral Vector (LVV), suspension bioreactor platforms, experimental design, process characterization, scale-up/tech transfer, Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, external CDMOs, Lean practices, digital tools, scheduling, data integrity, reproducibility, KPIs, titer, infectivity, impurity profiles, cycle time, right first time, single-use systems, process automation/PAT, digital lab systems (ELN/LIMS), statistical DOE, data analytics tools, cGMP interfaces, change control, sampling plans, CMC sections, technical responses, Lean/continuous improvement, robust documentation/knowledge management","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":108473.6,"maxValue":162710.4,"unitText":"YEAR"}}}]}