{"id":3988969,"url":"https://alion.io/job/predicine-scientist-ivd-product-development-validation","title":"Scientist, IVD Product Development & Validation","company":{"id":4458536,"name":"Predicine","domain":"predicine.com","url":"https://alion.io/company/predicine","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"MedTech","role_family":"MedTech","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":["Hayward, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Next-Generation Sequencing","optional":false}],"status":"live","first_seen_at":"2026-08-28T22:11:00Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-11-09T22:41:22Z","board_verified":true,"closed_at":null,"days_open":73,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":73},"description":"About Predicine Inc.\nPredicine Inc. is a Silicon Valley-based global precision diagnostic company committed to developing first- and best-in-class liquid biopsy cancer diagnostics assays. We provide innovative blood- and urine-based molecular diagnostic tests to enable precision medicine. Predicine's liquid biopsy platform and molecular insight solutions help biopharma companies accelerate drug development and expand discovery in oncology. We partner with the top 10 leading global biopharma companies to support biomarker-driven clinical trials across the US, EU, and APAC, including China. At Predicine, we believe people are our most important asset, and we're dedicated to creating a great place to work - one built on creativity, integrity, accountability, productivity, and teamwork.\nJob Summary\nWe are seeking a highly motivated Scientist to support the development, analytical validation, and regulatory submission of Predicine's NGS-based IVD products. This position will play a key role in designing and executing analytical validation studies, analyzing and interpreting validation data, preparing technical documentation, and supporting regulatory submissions. The scientist will work closely with cross-functional teams - including Laboratory Operations, Quality, Regulatory, and Bioinformatics - to ensure validation studies are scientifically sound, executed according to approved protocols, and completed within established timelines. The ideal candidate brings strong experience in molecular biology and/or NGS, excellent experimental and analytical skills, strong attention to detail, and genuine interest in applying scientific knowledge to regulated IVD product development.\nWhat You'll Do\nKey Responsibilities & Time Allocation\n30% - Validation Study Design & Execution - Design and execute validation studies for NGS-based IVD assays in accordance with design control and applicable regulatory requirements; develop and review study protocols, experimental plans, and acceptance criteria based on intended use, product requirements, risk assessment, and regulatory expectations.\n20% - Study Coordination & Data Generation - Coordinate sample preparation, laboratory testing, and data generation to ensure studies are executed according to approved protocols and timelines; support investigation and resolution of unexpected results, study deviations, and other validation-related issues.\n20% - Technical Documentation - Prepare and maintain validation protocols, reports, technical summaries, and other product development documentation; ensure technical documents are scientifically accurate, complete, traceable, and consistent with applicable regulatory and quality requirements.\n20% - Regulatory Submission Support - Support preparation of technical documentation required for regulatory submissions and reimbursement assessments; organize and maintain validation data and supporting documentation to ensure readiness for regulatory review.\n10% - Cross-Functional Collaboration & Presentation - Present validation results and technical conclusions to cross-functional teams and stakeholders; work closely with Regulatory and Quality teams to ensure submission materials are complete, consistent, and aligned with applicable requirements.\nRequired Skills & Qualifications\nStrong skills in experimental design, data organization, and result interpretation\nFamiliarity with laboratory procedures, SOPs, and instruments\nCritical thinking and effective troubleshooting skills\nSolid knowledge of NGS-related research areas such as NGS, molecular biology, genetics, cancer biology, or related areas\nWillingness to work in the lab and learn FDA and other regulatory authorities' guidelines on general principles related to validations\nProficient reading and communication skills\nHighly self-motivated with a strong sense of urgency\nEducation\nMinimum Preferred\nPhD in Molecular Biology or a closely related field or Bachelor's/Master's degree with 3+ years of applicable technical experience\nField of Study\nMolecular Biology or closely related field\nExperience Preferred\nPhD holders: no additional minimum experience specified\nNon-PhD candidates: 3+ years of technical experience in applicable areas such as NGS or oncology\nJoin Us\nAt Predicine, you won't just run experiments - you'll help bring regulated, first-of-their-kind cancer diagnostics from the lab to real-world clinical use. If you're detail-driven, scientifically rigorous, and want to make a direct impact on how cancer is diagnosed, we want to hear from you.\nApply today and help us turn breakthrough science into better patient outcomes.\n Predicine is an Equal Opportunity Employer. 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