{"id":2138860,"url":"https://alion.io/job/if-you-do-not-ag-research-associate-ii-validation","title":"Research Associate II, Validation","company":{"id":3822908,"name":"IF YOU DO NOT AG","domain":"genalyte.com","url":"https://alion.io/company/genalyte","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"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":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":32,"max":36,"currency":"USD","period":"hour","gross":null,"usd_annual":72000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Chromatography","optional":false},{"name":"Design Controls","optional":false},{"name":"FDA 510(k)","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-09T01:41:39Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-30T13:52:44Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"ABOUT GENALYTE\nAt Genalyte, we’re revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn’t be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.\nWHY WORK FOR US\nJoining Genalyte at this pivotal pre-commercial stage means your work will have real, visible impact - on our technology, our culture, and ultimately on how diagnostic testing is delivered to patients. Regardless of your role, you'll be part of a collaborative team working closely with leadership to build something meaningful from the ground up. Genalyte offers competitive compensation including base salary, significant equity participation, and a comprehensive benefits package. This is a rare opportunity to grow alongside a high-impact company at a genuinely exciting moment in its journey.\nPOSITION SUMMARY\nThe Research Associate II works independently under supervision to assist and support the designing, optimization and validation of new immunoassays on the Genalyte Merlin(™) platform. In this role, you’ll be responsible for verification and validation testing of new products and changes to released products. The Research Associate II contributes to verification and validation (V&V) activities for multiple systems comprising assays, reagents, consumables, instruments, and software. The role requires a strong detail-focused skill set to execute tests of products exiting development and to further support and improve products within manufacturing. This position works an alternative workweek schedule of four 10-hour days, Sunday through Wednesday.\nESSENTIAL FUNCTIONS & RESPONSIBILITIES\nThese may include but are not limited to:\nFollows established procedures to assist in design analysis on components and/or assemblies to assist in the development process of quantitative immunoassays for submission to the FDA for 510(k) clearance assessing the product under design control process from concept to product launch\n\nWorks independently under the guidance of a supervisor or senior team member and follows provided instructions to manage laboratory equipment and coordinate test station setups in support of product development, in accordance with established procedures\n\nAnalyze data for assay and process improvement and report findings to team and senior leadership\n\nExecutes experiments and validation protocols, supports problem-solving and trouble-shooting activities with guidance from Team Lead & Manager\n\nMeet milestones for product development timelines\n\nWork as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel\n\nMaintain compliance with all company policies, quality systems, design control and procedures\n\nDocument results, protocols, SOPs, etc\n\nSupports product improvement and manufacturing optimization\n\nEDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES\nA Bachelor’s degree in Biology, chemistry, biochemistry or similar with 2+ years of experience in Assay Development\n\nExperience with design control, complex systems and assays\n\nExperience in GDP/GMP/GLP\n\nExperience with team direction and mentorship\n\nExperience with FDA and 510(k) submission process preferred\n\nStandard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)\n\nAnalytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.) preferred\n\nGeneral presentation & spreadsheet analysis software\n\nTRAVEL REQUIREMENTS\nMinimal; occasional travel to clinical sites (\nPHYSICAL REQUIREMENTS & WORK ENVIRONMENT\nThe work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nCOMPENSATION\nThe base range for this role is $32 - $36 per hour. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base pay, this role includes meaningful equity participation, eligibility for the target bonus plan, and a comprehensive benefits package).\nEQUAL EMPLOYMENT OPPORTUNITY\nGenalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 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