The IVD Assay Development Senior Scientist I 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.
Key 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 R&D, Quality, Regulatory Affairs, and Engineering teams.
Participate in technical discussions and project meetings.
Design and execution of 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
Requirements
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), enzymatic assays, and 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).
Excellent documentation and communication skills.
The base salary range for this full-time position is $140,000 - $165,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.
