Senior Scientist I, Product Development

The role

This role focuses on downstream product development including QC method development, analytical strategy, verification and validation, and technology transfer. The person will work at the interface of R&D and Operations to ensure products are robust, scalable, and suitable for manufacturing and commercialization.

What you will do

• Design and execute verification and validation (V&V) studies to assess performance characteristics.
• Lead end-to-end product development with ownership across the full product lifecycle.
• Design, develop, and optimize QC methods to characterize assay performance, reagent quality, and product consistency.
• Lead or support product and process transfers to Manufacturing and QC team.
• Collaborate cross-functionally with R&D, Manufacturing, QC, Quality, and Engineering teams.
• Lead or support root cause investigations and continuous improvement initiatives.

Required qualifications

• D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years of relevant industry experience, or an M.S. with 8+ years of relevant industry experience.
• Demonstrated experience leading or supporting NPI and product transfer initiatives for commercial biotech tools or diagnostic products.
• Strong expertise in QC method development, analytical validation, and technology transfer to Manufacturing.
• Experience authoring technical documentation, including SOPs, validation reports, and technology transfer documents.
• Strong problem-solving, troubleshooting, and analytical skills.
• Experience with immunoassays (e.g., ELISA, MSD, Simoa) and molecular assays (e.g., qPCR, ddPCR, NGS).
• Experience working in IVD or other regulated environments, with familiarity with quality systems such as ISO 13485.
• Familiarity with statistical analysis tools such as JMP.
• Understanding of manufacturing scale-up, process robustness, and product commercialization considerations.
• Demonstrated ability to work effectively in cross-functional teams through open communication, constructive collaboration, and shared accountability.

Benefits

• benefits

Before you apply

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

About the company

Alamar develops innovative approaches to measure critical protein biomarkers from liquid samples. The team works to enable scientific discoveries that translate into clinical outcomes and benefit patients.