Senior Scientist I, IVD Assay Development

6 hours ago

Fremont, California, United States Alamar Biosciences Full time $140,000 - $165,000 per year

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 IVD Assay Development Senior Scientist I 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.

Key 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 R&D, Quality, Regulatory Affairs, and Engineering teams.
  • 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

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), enzymatic assays, and molecular techniques (qPCR, sequencing).
  • Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO
  • Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).
  • Excellent documentation and communication skills.

The base salary range for this full-time position is $140,000 - $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. 

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