Senior Scientist Assay Development 1

Senior Scientist I - IVD Assay Development Fremont, California

Position Summary

The Senior Scientist I - IVD Assay Development will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications. This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization.

Duties and Responsibilities

• Develop IVD assays for FDA and other global regulatory approval/clearance
• Design and execute experiments to develop IVD assays and establish assay performance specifications (sensitivity, specificity, reproducibility)
• Optimize and troubleshoot assays to meet performance expectations
• Transfer assay designs to tech transfer and manufacturing; define QC measures and support scale-up activities
• Work closely with Quality, Regulatory Affairs, Engineering, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness
• Participate in technical discussions and project meetings
• Design and execute verification and validation (V&V) studies, including all testing and documentation
• Perform data analysis and generate study reports suitable for regulatory review
• Identify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvements
• Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies
• Perform other duties as required

Qualifications

• * Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields
• * 5+ years in IVD assay development and validation * Hands-on experience with immunoassay formats (ELISA, chemiluminescent), and/or molecular techniques (qPCR, sequencing)
• * Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485) * Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software)

Please Note

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