Senior Scientist - IVD Assay Development & Validation

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

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.