{"id":4177188,"url":"https://alion.io/job/foundation-medicine-scientist-ii-diagnostic-development-validation","title":"Scientist II, Diagnostic Development & Validation","company":{"id":176045,"name":"Foundation Medicine","domain":"foundationmedicine.com","url":"https://alion.io/company/foundation-medicine","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","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":"2026-11-12T10:38:37Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":127450,"max":159300,"currency":"USD","period":"year","gross":null,"usd_annual":159300},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"LIMS","optional":false},{"name":"Next-Generation Sequencing","optional":false},{"name":"HIPAA","optional":true}],"status":"live","first_seen_at":"2026-11-12T15:02:39Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-13T16:23:25Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About the Job\nThe Scientist II, Diagnostic Development & Validation supports the full development lifecycle, from concept through commercial launch, of new NGS-based assays under 21 CFR part 820 QSR Design Control. This position contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance. The position requires validation test planning as well as hands-on execution in the laboratory.\nRegular onsite work at a designated FMI location is an essential function of this role.\nKey Responsibilities\nPrepare and handle biological specimens (blood, plasma, FFPE samples, nucleic acids).\nDevelop, verify, and validate novel diagnostic NGS assays.\nProcess samples using automated workflows and LIMS.\nLead training and performance qualification during technology transfers.\nDocument experimental data and present findings internally and externally.\nAnalyze data and generate study reports for regulatory submissions (e.g., FDA).\nPrepare and organize study reagents.\nMaintain QSR-compliant documentation for CDx assay development.\nCollaborate with QA and Regulatory teams to meet audit and accreditation standards.\nEstablish and validate performance parameters and QC for critical reagents.\nSupport timely processing and reporting of oncology samples.\nTroubleshoot and enhance assay capabilities and technical robustness.\nCollaborate with cross-functional teams (molecular biology, computational, regulatory).\nInterpret data and optimize assay features.\nDesign and conduct feasibility, development, and validation studies.\nDraft and maintain SOPs and documentation within the Quality Management System.\nMonitor and evaluate emerging analytical technologies.\nPresent scientific and technical data clearly to diverse audiences.\nContribute to project deliverables aligned with timelines.\nPerform other duties as assigned.\nComply with FMI's attendance policies\nQualifications\nBasic Qualifications\nBachelor’s Degree in chemical, physical or biological science, or medical technology and 4+ years of industry experience; OR,\nMaster’s Degree in chemical, physical or biological science, or medical technology and 2+ years of industry experience\nPreferred Qualifications\nAdvanced Degree (Master’s Degree or PhD) in Molecular Biology, Biochemistry or Genetics\n6+ years of commercial science experience in Molecular Biology or Biochemistry\nCurrent California Clinical Laboratory Science or Clinical Molecular Biology license\nStrong scientific understanding of molecular biology and genomics\nExtensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq, NGS library preparation and target-enrichment\nExperience developing, implementing and supporting high complexity clinical assays\nExperience within the following regulated environments: Food and Drug Administration - Quality System Regulation, Clinical Laboratory Improvements Amendments, International Organization for Standardization, and CAP; experience writing standard operating procedures, validation protocols and data reports within these environments\nExperience with Hamilton products, robotic liquid handlers, lab automation and instrumentation\nDemonstrated ability to clearly communicate scientific results in internal and external presentations and publications\nDemonstrated history of meeting individual and collaborative project deadlines\nin development, optimization, validation, and implementation of QSR or CLIA-certified tests including writing SOPs and validation plans/reports\nDemonstrated track record of timely completion of projects in an industry setting\nExcellent technical writing, presentation, and communication skills\nDetail oriented with excellent prioritization and organizational skills\nAbility to work in the presence of chemicals and reagents\nCompetent in complex molecular biology techniques, including NGS workflows\nScientific thought process and understanding of assay parameters illustrating creative approaches to problem solving to inform assay troubleshooting and optimization\nStrong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues\nUnderstanding of HIPAA and the importance of patient data privacy\nCommitment to reflect FMI’s values: Integrity, Courage, and Passion\nThe expected salary range for this position based on the primary location of Boston, MA is $127,450 - $159,300 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.\n#LI-Onsite","description_format":"text","description_chars":4981,"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":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Genomics & Genetic Testing","Precision Medicine","Medical Laboratories"],"lifecycle":[{"event":"open","at":"2026-11-12T16:24:29Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 26 · green card filings: 11","filings_12m":26,"filings_prev_12m":23,"green_card_filings_12m":11,"median_offered_wage_usd":136959,"route":null,"cap_exempt":false,"checked_at":"2026-11-12T07:36:15+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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":57,"reasons":["conf:6","win:early"],"computed_at":"2026-11-13T22:45:43Z"},"pay":{"stated_usd_annual":159300,"is_top_pay":true},"html_url":"https://alion.io/job/foundation-medicine-scientist-ii-diagnostic-development-validation","json_url":"https://alion.io/job/foundation-medicine-scientist-ii-diagnostic-development-validation.json","meta":{"generated_at":"2026-11-13T22:45:43Z","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":45382,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":176045},"rest":"https://alion.io/mcp/rest/get_company?id=176045"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffoundation-medicine-scientist-ii-diagnostic-development-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Ffoundation-medicine-scientist-ii-diagnostic-development-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Ffoundation-medicine-scientist-ii-diagnostic-development-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/foundation-medicine-scientist-ii-diagnostic-development-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffoundation-medicine-scientist-ii-diagnostic-development-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4177188}},{"tool":"search_jobs","arguments":{"company":"foundationmedicine.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4177188},"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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