{"id":285517,"url":"https://alion.io/job/legend-biotech-investigations-supervisor","title":"Investigations Supervisor","company":{"id":12179,"name":"Legend Biotech","domain":"legendbiotech.com","url":"https://alion.io/company/legend-biotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":92,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":57,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Raritan, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110706,"max":145303,"currency":"USD","period":"year","gross":null,"usd_annual":145303},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-26T14:29:30Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-11-04T11:45:43Z","board_verified":true,"closed_at":null,"days_open":69,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":69},"description":"Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.\nLegend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.\nLegend Biotech is seeking an Investigations Supervisor as part of the Manufacturing & Supply team based in Raritan, NJ. \nRole Overview\nThe CAR -T Investigation Supervisor will work with the investigation team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.\nKey Responsibilities\nSupport area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.\nAssign investigations to team members and track them to completion\nFollow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.\nPerform investigations and train new investigators.\nCollaborate with team to determine if corrective actions adequately addressed root cause of NC event.\nSupport tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.\nIdentify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.\nImplement process improvements within the change control system.\nRecognize and act on potential compliance issues and opportunities for process changes/improvement.\nPartner with all stakeholders to implement process improvements.\nAssure regulatory compliance and technical feasibility of proposed changes.\nServe as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.\nServes as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).\nMaintains various databases of production information.\nSupport coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).\nReview and approve SOP and Batch record revisions. \nJob duties performed routinely require exposure to and handling of biological materials and hazardous chemicals\nRequirements\nBS/BA required in technical discipline: Engineering, science or similar field.\nA minimum of six (6) years of professional relevant business experience.\nDemonstrated experience in completing complex investigations independently.\nKnowledge and solid understanding of cGMP regulations and FDA/EU guidance\nAbility to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.\nExcellent written and oral communication skills\nAbility to respond to sensitive inquiries or complaints from top managers, regulatory agencies, or members of the business community.\nExperience with internal and external regulatory audits.\nAbility to utilize various standard programs for data entry and word processing.\nLanguage(s): English\nThe base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.\nOther Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.\nBenefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.\nPay Range (Base Pay):\n$110,706—$145,303 USD\nPlease note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.\nWork Authorization & Employment Eligibility\nApplicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.\nEEO Statement\nIt is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.\nEmployment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.\nFor information related to our privacy notice, please review: Legend Biotech Privacy Notice.","description_format":"text","description_chars":7100,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Equity","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-05T13:59:11Z"},{"event":"close","at":"2026-10-15T17:17:50Z"},{"event":"reopen","at":"2026-10-16T21:35:19Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 26 · green card filings: 3","filings_12m":26,"filings_prev_12m":27,"green_card_filings_12m":3,"median_offered_wage_usd":116466,"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)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.762,"p_room":0.44,"age_days":69,"expected_fill_days":57,"reasons":["conf:4","win:tail","crowd:"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":145303,"is_top_pay":true},"html_url":"https://alion.io/job/legend-biotech-investigations-supervisor","json_url":"https://alion.io/job/legend-biotech-investigations-supervisor.json","meta":{"generated_at":"2026-11-04T12:52:10Z","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":19407,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":12179},"rest":"https://alion.io/mcp/rest/get_company?id=12179"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flegend-biotech-investigations-supervisor"},{"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%2Flegend-biotech-investigations-supervisor"},{"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%2Flegend-biotech-investigations-supervisor"},{"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/legend-biotech-investigations-supervisor\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flegend-biotech-investigations-supervisor"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":285517}},{"tool":"search_jobs","arguments":{"company":"legendbiotech.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":285517},"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. Docs: https://alion.io/developers"}}