{"id":782162,"url":"https://alion.io/job/immunitybio-senior-scientist-regulatory-cmc","title":"Senior Scientist, Regulatory CMC","company":{"id":449855,"name":"ImmunityBio","domain":"immunitybio.com","url":"https://alion.io/company/immunitybio","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","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":["Summit, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":140000,"max":154000,"currency":"USD","period":"year","gross":null,"usd_annual":154000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-08-25T00:00:00Z","employer_posted_date":"2026-08-25","last_verified_at":"2026-11-02T22:48:19Z","board_verified":true,"closed_at":null,"days_open":70,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":70},"description":"Company Overview\n ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. \nWhy ImmunityBio?\n\n ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.\n\n Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.\n\n Work with a collaborative team with the ability to work across different areas of the company.\n\n Ability to join a growing company with professional development opportunities.\nPosition Summary\nThe Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.\nEssential Functions\nPrepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards.\nSupport the development of global CMC regulatory strategies.\nAssist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation.\nProvide input and recommendations on CMC topics planned or performed.\nSupport the design of CMC protocols.\nInteract with other groups when needed to address CMC related matters.\nAssist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues.\nMay train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate.\nPerform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.\nEducation & Experience\nBachelor’s Degree in life sciences or technical discipline with 6+ years’ relevant progressive experience required; or\nMaster’s Degree in life sciences or technical discipline with 4+ years’ relevant progressive experience required; or\nDoctorate degree in life sciences or technical discipline with 2+ years’ relevant progressive experience required.\nExperience in the preparation of the submission of CMC modules in eCTD format required\nFamiliarity with organizing responses to Health Authority requests required\nFamiliarity with regulatory submissions outside of the US a bonus\nKnowledge, Skills, & Abilities\nKnowledge of Health Authority procedures and guidance regarding document management and electronic submission\nKnowledge of Health Authority CMC guidance documents and requirements\nProficient in Electronic Document Management Systems\nAbility to work with firm deadlines and adapt quickly to changing requirements and priorities\nStrong organizational skills, written and oral communication skills, and attention to detail\nKnowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired\nWorking Environment / Physical Environment\nThis position works on site in Summit, NJ.\nRegular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.\nThis position may need to sit for long periods of time and use various computer programs.\nThis desk-based role involves the close study of scientific and regulatory documents.\nThis position will work closely with scientific colleagues throughout the day, often on a project team basis.\nThis position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.\n$140,000 (entry-level qualifications) to $154,000 (highly experienced) annually\nThe application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.\nImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.\nImportant: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.\nWe are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.\nImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options\nHealth and Financial Wellness Programs\nEmployer Assistance Program (EAP)\nCompany Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability\nHealthcare and Dependent Care Flexible Spending Accounts\n401(k) Retirement Plan with Company Match\n529 Education Savings Program\nVoluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks\nPaid Time Off (PTO) includes: 11 Holidays\nExempt Employees are eligible for Unlimited PTO\nNon-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day\nWe are committed to providing you with the tools and resources you need to optimize your Health and Wellness.\nAt ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.","description_format":"text","description_chars":7627,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development","Retirement plans","Unlimited PTO","Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-12T00:59:56Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 9","filings_12m":9,"filings_prev_12m":3,"green_card_filings_12m":0,"median_offered_wage_usd":142500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.656,"p_room":0.36,"age_days":69,"expected_fill_days":35,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-11-02T06:13:15Z"},"pay":{"stated_usd_annual":154000,"is_top_pay":false},"html_url":"https://alion.io/job/immunitybio-senior-scientist-regulatory-cmc","json_url":"https://alion.io/job/immunitybio-senior-scientist-regulatory-cmc.json","meta":{"generated_at":"2026-11-03T00:02:47Z","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":117,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":449855},"rest":"https://alion.io/mcp/rest/get_company?id=449855"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fimmunitybio-senior-scientist-regulatory-cmc"},{"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%2Fimmunitybio-senior-scientist-regulatory-cmc"},{"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%2Fimmunitybio-senior-scientist-regulatory-cmc"},{"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/immunitybio-senior-scientist-regulatory-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fimmunitybio-senior-scientist-regulatory-cmc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":782162}},{"tool":"search_jobs","arguments":{"company":"immunitybio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":782162},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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