Senior Scientist I - IVD Assay Development
Alamar Biosciences, Inc. · Fremont, CA · 1 mo ago
AnalystFull-time
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
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)
Pay
The base salary range for this full-time position is $150,000 - $165,000 + bonus + equity + benefits.