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 experienced scientists to manage new assay development projects. This will include bench level development of protein assays for clinical diagnostics on a proprietary microfluidic platform. Responsibilities will include reagent selection, assay development, analytical/clinical studies for regulatory submissions. 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, following design control.
- Identify and implement optimal reagents for the development of specific immunoassay tests to achieve substantial equivalence to predicate assay and meet requirement for manufacturing scale up.
- Lead analytical and clinical studies throughout development to meet assay specification for market launch.
- Lead assay optimization to achieve performance with respect to sensitivity, specificity and precision requirements while addressing sample matrix effects (i.e., running assay with whole blood sample or serum/plasma).
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
- Industry experience in leading immunoassays development activities for clinical diagnostics, with good track record in troubleshooting assay and bringing assay to clinical trials. Exposure to microfluidic device technology is a plus.
- Familiarity with CE and FDA regulatory requirements for IVD products, product development under design control, and specificities of devices for use in the point-of-care.
- Ph.D. (or M.S.) education in the fields of biochemistry, bioengineering or chemistry.
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