Alamar Biosciences

Senior Scientist I - IVD Assay Development

Fremont, California · Senior · Full-time

Sponsorship not specified$150k-$165kDetected 34 days ago

Data AnalysisComplianceProduct ManagementFDA RegulatoryqPCRMolecular BiologyMedical DevicesProtein AnalysisCollaborationRegulatory Affairs

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

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

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.

Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies

This listing is sourced directly from Alamar Biosciences's careers page and normalized into a canonical job model.