Senior Scientist I - IVD Assay Development

Alamar Biosciences, Inc.; Iowa (LA); On-site; USD 150,000 - 165,000; Full time

Job summary

Alamar Biosciences, Inc. seeks a Senior Scientist I - IVD Assay Development to lead design, development, optimization, and validation of clinical assays.

This role involves hands-on lab work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization. You will work with Quality, Regulatory Affairs, Engineering, Product Management, Tech Transfer, and Manufacturing to meet milestones and ensure readiness for market release.

Qualifications

• 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 global regulatory approvals.
• Design and execute experiments to 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.
• Collaborate 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.

Skills

Immunoassays

Molecular techniques

Data analysis

Regulatory knowledge

Education

PhD or MS in Biochemistry / Molecular Biology / Immunology

Tools

Excel

GraphPad Prism

Statistical software

Job description

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.

Position Summary

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.

Duties and Responsibilities

• Develop IVDassaysfor 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

Qualifications

• 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).

The base salary range for this full-time position is $150,000 - $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.

Please Note - We participate in E-Verify to confirm authorization to work in the United States.