Research Associate I/II, Validation
About The Position
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.
Requirements
- 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
- Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)
- General presentation & spreadsheet analysis software
Nice To Haves
- Experience with team direction and mentorship
- Experience with FDA and 510(k) submission process preferred
- Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.) preferred
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
- 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
Benefits
- competitive salary
- health, dental, and vision insurance
- generous paid time off
- stock ownership and equity participation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
51-100 employees
