{"id":2092033,"url":"https://alion.io/job/astrazeneca-associate-director-analytical-sciences-potency-bioassay-development","title":"Associate Director, Analytical Sciences – Potency & Bioassay 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":"Science & Research","role_family":"Science & Research","seniority":"head","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":138000,"max":207000,"currency":"USD","period":"year","gross":null,"usd_annual":207000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-08T14:55:58Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-11T19:07:10Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"At AstraZeneca, we are pushing the boundaries of science to deliver life-changing cell and gene therapies to patients. We are seeking a scientific leader to drive potency and functional bioassay development within our Analytical Sciences organization, supporting products from early development through commercialization.\nIn this role, you will set the technical strategy for phase-appropriate potency and bioassay methods, build organizational capability in cell-line engineering and gene-editing-enabled analytics, and partner across CMC functions to ensure robust product characterization, release, stability, and comparability. You may also serve as Analytical Lead for programs advancing toward late-stage development and launch. This role is based out of Santa Monica, CA and reports to the Director, Product Analytical Sciences.\nWhat You'll Do\nLead analytical strategy for potency and functional bioassays across the cell therapy portfolio, defining phase-appropriate approaches from early development to commercial launch.\nDevelop, qualify, validate, and lifecycle-manage cell-based potency and functional assays - including cytotoxicity, proliferation, activation, cytokine production, reporter-based assays, and multiparametric flow cytometry.\nBuild cell-line engineering and banking capabilities, including design of engineered target and reporter lines, clone selection, characterization, and critical reagent control to support transferable, commercial-ready methods.\nApply CRISPR/gene-editing, viral and non-viral delivery, and molecular biology expertise to enable analytics for autologous, allogeneic, and emerging in vivo therapies.\nDrive method robustness using QbD, DOE, risk-based development, and sound statistical approaches.\nLead method transfer to internal QC, external labs, and manufacturing partners, including protocol and report authorship.\nPartner with Process Development on process characterization, comparability, and linking process parameters to product quality attributes.\nServe as Analytical Lead on CMC program teams as appropriate, owning strategy, risks, timelines, and regulatory deliverables.\nAuthor analytical sections of regulatory submissions (INDs through BLA) and responses to health authority queries.\nEvaluate and implement emerging technologies and automation to improve robustness, throughput, and scalability.\nMentor and develop scientists, fostering strong experimental design and technical judgment across the team.\nEssential Qualifications\nPhD in Immunology, Cell Biology, Molecular Biology, Biochemistry, Bioengineering, or related discipline with 6+ years of relevant experience; or MS with 8+ years; or BS with 10+ years.\nSubstantial analytical development experience in cell therapy, gene therapy, or biologics within a regulated environment. \nProven expertise developing and qualifying cell-based potency/functional assays suitable for QC use.\nStrong knowledge of immune cell biology (T-cell and/or NK-cell) and relevant signaling mechanisms.\nHands-on experience with multiparametric flow cytometry and other cell-based analytical platforms.\nDeep understanding of the analytical method lifecycle - development, qualification, validation, transfer, and lifecycle management.\nExperience authoring analytical content for regulatory submissions.\nDemonstrated ability to lead cross-functional scientific programs and influence technical strategy.\nStrong communication, mentorship, and scientific leadership skills.\nPreferred skills\nDirect experience engineering, characterizing, and banking mammalian cell lines as assay substrates, targets, or reporters.\nExperience establishing critical reagent and cell bank strategies for late stage/commercial methods.\nExperience with CRISPR and gene-editing analytics (knockout confirmation, copy number, off-target assessment).\nBroad molecular biology toolkit: PCR, qPCR, ddPCR, NGS, cloning.\nExperience across autologous, allogeneic, and in vivo modalities, including viral-vector characterization.\nLate-stage analytical experience supporting comparability, validation, or BLA filings.\nPrior role as Analytical/Technical Lead on a CMC team.\nExperience implementing lab automation or high-throughput platforms.\nProficiency with JMP, Prism, FlowJo, SoftMax Pro, or equivalent.\nThe annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for various 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.\nDate Posted\n08-Oct-2026Closing Date\n14-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":5193,"description_truncated":false,"requirements":{"experience_years_min":6,"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":["Drug Discovery","Oncology Therapeutics","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-08T14:55:58Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":15,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":207000,"is_top_pay":false},"html_url":"https://alion.io/job/astrazeneca-associate-director-analytical-sciences-potency-bioassay-development","json_url":"https://alion.io/job/astrazeneca-associate-director-analytical-sciences-potency-bioassay-development.json","meta":{"generated_at":"2026-10-11T20:14:51Z","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":7906,"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-associate-director-analytical-sciences-potency-bioassay-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-associate-director-analytical-sciences-potency-bioassay-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-associate-director-analytical-sciences-potency-bioassay-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-associate-director-analytical-sciences-potency-bioassay-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastrazeneca-associate-director-analytical-sciences-potency-bioassay-development"}]}