Senior Scientist II, IVD Assay Development

Описание вакансии

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 

• Lead development and optimization of IVD immunoassays on Alamar’s proprietary NULISA technology.
• Design and execute experiments to optimize and troubleshoot assays to meet performance expectations.
• Support technology transfer from R&D to manufacturing.
• Define QC measures and support scale-up activities.
• Work closely with Quality, Regulatory Affairs, and Engineering teams.
• Participate in technical discussions and project meetings.
• Design and execute verification and validation studies, including planning, laboratory testing, data analysis, and documentation of results.
• Work closely with Quality, Regulatory Affairs, Engineering/Software, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness.
• Support regulatory submission document preparation.
• Contribute to Design History File (DHF)–aligned documentation.
• 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.
• 3–5+ 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 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 $165,000 - $180,000 + 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.