Senior Scientist I - IVD Assay Development

Alamar Biosciences•Fremont, CA

13h

About The Position

At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission. 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.

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), 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).

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