{"id":1303195,"url":"https://alion.io/job/nitto-denko-scientist-asat","title":"Scientist, ASAT","company":{"id":2066639,"name":"Nitto Denko","domain":"nitto.com","url":"https://alion.io/company/nitto-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Milford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":93300,"max":113800,"currency":"USD","period":"year","gross":null,"usd_annual":113800},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-21T00:00:00Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-15T11:09:56Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"About this opportunity :\nThe ASAT Scientist supports analytical method transfer, laboratory implementation, analyst training, and lifecycle management for oligonucleotide clinical and commercial programs. This role partners with Quality Control (QC), Analytical Development (AD), Manufacturing, Quality Assurance, and clients to ensure analytical methods are successfully transferred, implemented, and executed in GMP laboratories. The position provides hands-on laboratory support while developing expertise in analytical technologies, method lifecycle management, and technical leadership.\nKey Responsibilities:\nSupport analytical method transfers from clients, AD, and cross-site laboratories into QC, including readiness assessments, implementation activities, training support, and deployment into GMP operations.\nExecute laboratory activities associated with method transfer, qualification, verification, co-validation, and implementation while ensuring accurate documentation and GMP compliance.\nAssist in developing and maintaining method transfer requirements, risk assessment tools, implementation resources, and laboratory informatics solutions.\nProvide technical training, shadowing, and coaching for QC analysts during implementation and routine execution activities.\nTroubleshoot chromatographic, mass spectrometric, and related analytical methods and instrumentation under the guidance of senior technical staff.\nSupport deviations, OOS, OOT, PAC failures, data invalidations, and atypical investigations through data review, troubleshooting, hypothesis generation, and investigation execution.\nEvaluate root causes, support CAPA development, and escalate complex issues as needed.\nAssist with collection and review of method performance data, transfer metrics, investigation outcomes, and recurring laboratory issues to support trend analysis and continuous improvement.\nSupport ASAT tracking tools, dashboards, templates, documentation systems, and laboratory informatics solutions, including LIMS methods and workflows.\nAuthor and revise protocols, reports, training materials, technical assessments, method implementation documents, and other GMP documentation.\nExecute in-process, release, stability, and reference material testing as needed.\nRequired Skills/Abilities:\nBA/BS with 5+ years, MS with 3+ years, or PhD with 0-3 years of experience in AD, QC, or related analytical functions within the pharmaceutical or biotechnology industry, preferably within a CDMO.\nThis role serves as a cross-site technical resource and may require up to 10% travel.\nExperience working with chromatographic, mass spectrometric, or related analytical technologies.\nFamiliarity with analytical method transfer, testing, or implementation activities in a GMP environment.\nFamiliarity with analytical techniques used for oligonucleotide characterization and testing.\nExperience using analytical instrumentation and software platforms, including Agilent, Waters, or equivalent systems.\nExperience authoring GMP documentation, including SOPs, methods, protocols, reports, and training documents.\nFamiliarity with deviations, OOS, OOT, CAPA activities, and root cause investigation principles.\nKnowledge of GMP regulations, ICH guidelines, pharmacopeial requirements, data integrity principles, and laboratory compliance expectations.\nThe annualized salary range for this role is $93,300 - 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