Senior Scientist I - IVD Assay Development

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/Software, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness 
• 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 

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).  

The base salary range for this full-time position is $150,000 - $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.