Genalyte is seeking an experienced Assay Development Scientist III to join our growing Product Development team!
ABOUT THE ROLEThis position is within our R&D team developing new immunoassays on the Genalyte Maverick(™) platform. In this role, you’ll be a part of the team developing novel immunoassay technologies, optimizing robustness, reproducibility, and data quality, and ultimately delivering those assays through verification and validation.WHAT YOU'LL DOThese may include but are not limited to:
- Design, develop and optimize quantitative immunoassays on the Genalyte Maverick(™) system suitable 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 vendor & supplier relationships
WHAT YOU'LL NEED:
- 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, minitab or similar)
- Working with quality assurance and quality control teams
TECHNICAL KNOWLEDGE YOU'LL NEED:
- Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)
- Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.)
- General presentation & spreadsheet analysis software
- Mathematical curve fitting packages
- Statistical analysis software and routines
- Ideal candidate will have some familiarity with databases and SQL queries, coding in Python or similar environment
WHY JOIN USAt Genalyte, 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 flexible 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.SALARY RANGE: $100,000 - $140,000Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual’s skills, qualifications, business need and experience.
