Genalyte is seeking an experienced Assay Development Scientist III to join our growing Product Development team!
About The Role
This 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 Do
These 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.)
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 US
At 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 - $140,000
Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual’s skills, qualifications, business need and experience.
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet Publishing
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