Research Associate II, Validation

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.

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.

The 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.

• 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 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
• 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

• 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

Minimal; occasional travel to clinical sites (