Research Associate I/II, Validation

ABOUT GENALYTE

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. 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

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

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. This posting is intended to fill two open positions.

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 AND 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

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