{"id":2034503,"url":"https://alion.io/job/astrazeneca-senior-process-engineer-cell-therapy-process-development","title":"Senior Process Engineer, Cell Therapy Process Development","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":94,"open_postings":166,"ghost_share":0,"stale_share":0.416,"repost_share":0.054,"time_to_fill_p50_days":15,"computed_at":"2026-10-10T05:45:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santa Monica, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":96000,"max":144000,"currency":"USD","period":"year","gross":null,"usd_annual":144000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-07T15:28:42Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-11T19:07:10Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Position Summary\nWe are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA-enabling studies, and technology transfer to different manufacturing sites. \nThis position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment.\nThe ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.\nKey Responsibilities\nProcess development and characterization\nDesign, execute, and support autologous or allogenic cell therapy process optimization and robustness studies. \nDrive implementation of closed-system operations and automation strategies to support scalability and compliance. \nPlan and execute process characterization studies (DOE, multivariate studies, scale-down models, and scale-up assessments) in alignment with QbD and ICH guidelines. \nPerform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross-functional teams and governance forums. \nSupport development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters. \nConduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy 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 cell therapy processes. \nSupport technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record. \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 reviewing CMC documentation, including cell therapy 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 cell therapy manufacturing. \nCross-Functional Collaboration\nWork closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end-to-end process alignment. \nRepresent cell therapy characterization activities in technical meetings, reviews, and governance discussions. \nSupport lifecycle management, post-approval changes, and continuous improvement initiatives for cell therapy processes. \nRequired Qualifications\nPh.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands-on industry experience. \nStrong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation). \nDemonstrated experience with GMP operations and late-stage / commercial readiness. \nProven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels \nExperience with late-stage development, process characterization, and PPQ principles for cell therapy 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 with viral vector handling (Lentivirus, AAV) in manufacturing processes. \nFamiliarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors). \nExperience implementing closed, automated, or high-throughput systems. \nExperience designing and executing DOE and multivariate data analysis for cell therapy processes. \nExperience with JMP or similar statistical analysis tools.\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 $96K to $144K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.\n# Cell Therapy\nDate Posted\n07-Oct-2026Closing Date\n22-Oct-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.","description_format":"text","description_chars":6079,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Regenerative Medicine","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-07T15:28:42Z"}],"visa":[],"liveness":{"score":89,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.894,"p_room":1,"age_days":2,"expected_fill_days":15,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":144000,"is_top_pay":true},"html_url":"https://alion.io/job/astrazeneca-senior-process-engineer-cell-therapy-process-development","json_url":"https://alion.io/job/astrazeneca-senior-process-engineer-cell-therapy-process-development.json","meta":{"generated_at":"2026-10-11T20:49:25Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9238,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":13195},"rest":"https://alion.io/mcp/rest/get_company?id=13195"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fastrazeneca-senior-process-engineer-cell-therapy-process-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fastrazeneca-senior-process-engineer-cell-therapy-process-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fastrazeneca-senior-process-engineer-cell-therapy-process-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/astrazeneca-senior-process-engineer-cell-therapy-process-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastrazeneca-senior-process-engineer-cell-therapy-process-development"}]}