TITLE: SCIENTIST – PROJECT LEADER IN ASSAY DEVELOPMENT
Claros Diagnostics has developed and is commercializing a Point-of-Care diagnostic test system for rapid, laboratory quality multiplexed immunoassays. We are expanding the test menu and adapting new tests for the platform.
We are looking for bench-level scientists with strong skills in analytical biochemistry to manage the development of new assay on the Claros platform. The candidate will extend the capability of the platform to implement innovative antibody-based assay for clinical diagnostics applications. Responsibilities will include surface modification for the attachment of biological probes, protein conjugates preparation, reagent selection/optimization, protein assay development, analytical/clinical verification studies. Other cross-functional responsibilities include interfacing with quality control, regulatory affairs, external consultant interactions, and production scale-up. Contribute to and execute on clearly defined project plans and budgets. The candidate will report to the Director of Assay Development.
DUTIES AND RESPONSIBILITIES:
Assay Development:
- Technical lead of assay development team (1-3 FTE) with bench level work.
- Adapt innovative protein assays to the Claros biosensing system, encompassing surface modification, modification/conjugation of proteins and other bio-molecules, optimizing reagent and assay format to achieve reliable analytical performance to meet specifications.
- Lead analytical and clinical studies throughout development to meet assay specification for market launch. Participate to clinical studies to validate the use of the device for use as an in-vitro diagnostics.
Product Development:
- Interface with engineering team to contribute to potential assay-specific hardware/software adaptation of the Claros analyzer.
- Interface with manufacturing team to facilitate transfer of assay to manufacturing, contribute to generation and approval of technical documentation.
- Involved in the generation of Quality System documentation and approval activities (including: Design Input/Output & Specifications, Risk Assessment & Analysis (FMEA), and Design History Files), participate to schedule design review meeting, and assist in the submissions and review of responses to notified bodies and federal agencies relative to medical device directive compliance.
EDUCATIONAL REQUIREMENTS/EXPERIENCE
- Bench experience in academic or industry setting for the development of biosensors, strong analytical background chemistry, and good track record in troubleshooting assay methods. Exposure to microfluidic device technology is a plus.
- Familiarity with development of IVD products and associated regulatory framework is a plus.
- Ph.D. (or M.S.) education in the fields of biochemistry, bioengineering or chemistry.
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