Staff Scientist Assay Development

Job Description

We're supporting an innovative biotechnology company developing next-generation genomics and molecular detection platforms as they look to add a Staff Scientist, Assay Development to their growing team.

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This is an opportunity to play a key role in the development of FDA-regulated molecular diagnostic products, working at the intersection of assay chemistry, reagent development, validation, and commercialization.

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You'll focus on reagent formulation and optimization, stability and shelf-life studies, lyophilization, and analytical validation, helping to ensure robust, reproducible, and manufacturable assay performance. The position works closely with assay development, quality, regulatory, engineering, and manufacturing teams to advance products from development through commercialization.

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Key experience we're looking for:

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• Reagent development and formulation for molecular diagnostic or IVD products
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• Assay chemistry optimization and analytical performance improvement
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• Stability studies, accelerated aging, shelf-life determination, and lyophilization
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• FDA-regulated product development and analytical validation
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• Working knowledge of Design Controls, FDA 510(k), ISO 13485, and CLSI guidelines
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• Experience with PCR, qPCR, multiplex fluorescence assays, or related molecular diagnostic technologies preferred
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• PhD with 5+ years of industry experience, or MS with 8+ years of relevant experience
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This is an excellent opportunity for a scientist who enjoys solving complex assay development challenges and wants to have a direct impact on bringing novel diagnostic technologies to market.

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If you'd be interested in learning more or know someone who may be a fit, please get in touch.

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