Research Associate I/II, Validation

About the role

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. This is a rare opportunity to grow alongside a high-impact company at a genuinely exciting moment in its journey.

Position Summary

A 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.

Essential Functions & Responsibilities

• 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
• Milestone 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 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 (

Physical Requirements & Work Environment

This is a primarily office-based role in San Diego, CA. Occasional visits to laboratories may be required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

The base range for this role is $31.50 - $39 per hour. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, eligibility for the target bonus plan, and a comprehensive benefits package).

Equal Employment Opportunity

Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.