Scientist I​/Scientist 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.

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.

We are seeking a Scientist II to lead our Development & Validation operations and provide expertise across our organization on performing, developing and validating hematology, serology, and chemistry assays. In this role, you will lead with groups in R&D, Quality, Regulatory and Manufacturing. In addition to overseeing daily operational activities, you will play a significant role in product development including leading GLP studies for FDA submissions and contributing to resolving design transfer and quality control challenges.

You will also participate in research collaborations internally and with external partners. This posting is intended to fill two open positions.

• Draft and finalize protocols and reports for analytical studies
• Lead the existing team with strong competencies in serology, chemistry and other immunoassay practices and execution of controlled performance studies
• Design, develop and optimize quantitative immunoassays for submission to the FDA for 510(k) clearance assessing feasibility through initial phases and through the design control process
• Analyze data for assay and process improvement and report findings to team and senior leadership
• Investigate and troubleshoot problem areas to recommend product improvements
• 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
• Manage external studies in collaboration with key opinion leaders (KOLs) and support scientific publications
• Oversee collaborations with clinical trial partners, study sites, and contribute to any and all internal documents
• Actively communicates project status, challenges, concerns, and resource constraints to area management
• Writes design control documentation and executes/oversees associated test and risk management activities
• Works with R&D to develop, optimize and integrate assay V&V
• Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed
• Supports improvement verifications, validations, and transfers
• Develops, reviews, or approves execution protocols and group generated data
• Oversee studies, reviews protocol execution, and approves summary reports

• A minimum of a Master’s degree in chemistry, biochemistry or similar with 5+ years of experience in Assay Development
• Experience with team direction and mentorship
• Experience with FDA and 510(k) submission process
• Experience in some or all of the following areas:
  • Antibody and protein biochemistry, surface energy modification, assay development
  • Experimental design (DOEs, etc), statistical analysis, power analysis, and detailed understanding of precision, uncertainty, error propagation, etc. ○ 510(k) submissions and study requirements, verification and validation of assay designs
  • Chemical kinetics, silicon photonics, microfluidics
  • Experience with large data sets & analysis & software (jmp,…