{"id":1529122,"url":"https://alion.io/job/elevatebio-senior-specialist-ii-quality-control-validation","title":"Senior Specialist II, Quality Control Validation","company":{"id":3157164,"name":"ElevateBio","domain":"elevate.bio","url":"https://alion.io/company/elevate-bio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"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":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T14:22:00Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-20T23:17:13Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.\nThe Role\nThe Senior Specialist II, QC Validation role l is responsible for overseeing method validation and overall validation readiness within Quality Control at our Manufacturing facility. In this role, you’ll be responsible for developing validation plans/protocols, executing/organizing validation activities, analyzing data, documenting results, and maintaining compliance with regulatory standards for our cell and gene therapy programs transitioning from early clinical phase. In addition, this position will work closely with the Analytical Development, QC management, QC testing, and QA teams, as well as customers to ensure that validation objectives are met.\nHere’s What You’ll Do\nDefine the validation strategy, plan, and protocol for applicable methods based on regulatory requirements and industry standards, as well as client requirements.\nCollaborate with Analytical Development to ensure validation is consistent with, and utilizes, initial development, qualification, and method performance data.\nCollaborate with QC testing functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.\nAnalyze associated data and report validation results.\nEnsure test methods, associated equipment/software, and associated SOPs are appropriate for validation in preparation for commercial manufacturing. Collaborate on and oversee change controls, as needed.\nSupport inspections and facility audits.\nHire, train, and mentor supporting staff, as needed.\nRequirements\nB.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 8 years of experience in GMP QC laboratory setting, or M.S. in a similar discipline with a minimum of 6 years of experience.\nExpertise with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).\nAbility to communicate and work independently with scientific/technical personnel.\nStrong knowledge of GMPs, SOPs, and Quality system processes.\nStrong data analysis skills.\nExcellent organizational skills.\nExperience with method validations for commercial products.\nExperience in cell and gene therapy manufacturing environment is a plus.\nExperience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.\nPhysical and Environment Requirements:\nAbility to stand, walk, bend and stretch for extended period of time\nAbility to perform routine repetitive motions with use of arms, wrists and hands\nThe budgeted range for this position is $150,000 - $200,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. \nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.","description_format":"text","description_chars":3629,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-30T15:30:55Z"}],"visa":[],"liveness":{"score":61,"band":"ok","label":"Likely open","p_open":1,"p_active":0.814,"p_room":0.75,"age_days":19,"expected_fill_days":28,"reasons":["conf:3","win:late"],"computed_at":"2026-10-20T05:45:00Z"},"pay":{"stated_usd_annual":200000,"is_top_pay":true},"html_url":"https://alion.io/job/elevatebio-senior-specialist-ii-quality-control-validation","json_url":"https://alion.io/job/elevatebio-senior-specialist-ii-quality-control-validation.json","meta":{"generated_at":"2026-10-20T23:28:26Z","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":27068,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"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":3157164},"rest":"https://alion.io/mcp/rest/get_company?id=3157164"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felevatebio-senior-specialist-ii-quality-control-validation"},{"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%2Felevatebio-senior-specialist-ii-quality-control-validation"},{"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%2Felevatebio-senior-specialist-ii-quality-control-validation"},{"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/elevatebio-senior-specialist-ii-quality-control-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felevatebio-senior-specialist-ii-quality-control-validation"}]}