Alamar Biosciences
Senior Scientist I - IVD Assay Development
Fremont, California · Senior · Full-time
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About the role
- This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization.
- 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
Responsibilities
- The Senior Scientist I - IVD Assay Development will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications.
- 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)
- Transfer assay designs to tech transfer and manufacturing; define QC measures and support scale-up activities
- Design and execution of verification and validation (V&V) studies, including all testing and documentation
Requirements
- 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).
- Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields.
Skills
- Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies
Compensation
- $150k-$165k
Company info
- At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients.
- Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
This listing is sourced directly from Alamar Biosciences's careers page and normalized into a canonical job model.