Research Associate I/II, Validation at Genalyte

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

39.0

Posted On

30 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Assay Development, Design Control, GDP, GMP, GLP, FDA 510(k) Submission, Data Analysis, Validation Protocols, Immunoassays, Laboratory Equipment Operation, Analytical Chemistry, SOP Documentation

Industry

Biotechnology

Description

ABOUT GENALYTE At 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. WHY WORK FOR US Joining 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. POSITION SUMMARY Research Associate I/ II works under direct 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 Assay V&V RA 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. ESSENTIAL FUNCTIONS & RESPONSIBILITIES These may include but are not limited to: Follows 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 Works 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 Analyze data for assay and process improvement and report findings to team and senior leadership Executes experiments and validation protocols, supports problem-solving and trouble-shooting activities with guidance from Team Lead & Manager Meet milestones for product development timelines Work as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel Maintain compliance with all company policies, quality systems, design control and procedures Document results, protocols, SOPs, etc Supports product improvement and manufacturing optimization EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES A Bachelor’s degree in Biology, chemistry, biochemistry or similar with 2+ years of experience in Assay Development Experience with design control, complex systems and assays Experience in GDP/GMP/GLP Experience with team direction and mentorship Experience with FDA and 510(k) submission process preferred Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.) Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.) preferred General presentation & spreadsheet analysis software TRAVEL REQUIREMENTS Minimal; occasional travel to clinical sites (

Responsibilities

Support the design, optimization, and validation of new immunoassays on the Merlin platform. Execute verification and validation testing for products and changes to ensure compliance with FDA standards.