Scientist I - IVD Assay Development at Alamar… · Fremont

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 Scientist 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

• Support the development and optimization of IVD immunoassays on Alamar’s proprietary NULISA technology.
• Design and execute experiments to optimize assay performance and assist in troubleshooting activities.
• Assist with technology transfer activities from R&D to manufacturing.
• Support implementation of QC measures and scale-up activities.
• Collaborate cross-functionally with Quality, Regulatory Affairs, Engineering, and other teams.
• Participate in technical discussions and project meetings.
• Execute verification and validation studies, including laboratory testing, data analysis, and documentation of results.
• Support cross-functional teams (Quality, Regulatory Affairs, Engineering/Software, Product Management, Tech Transfer, and Manufacturing) to help meet program milestones.
• Assist in preparation of regulatory submission documentation.
• Contribute to Design History File (DHF)–aligned documentation.
• Stay current with relevant scientific advancements through literature review.
• Perform other duties as assigned.

Requirements

• Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields.
• 0-2+ 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 13485).
• 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 $120,000 - $140,000 + 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.