Senior Scientist I, Product Development

Responsibilities

• Design, develop, and optimize QC methods to characterize assay performance, reagent quality, and product consistency
• Define QC strategies across the product lifecycle, including raw material, in-process, and finished goods QC
• Design and execute V&V studies including precision, sensitivity, linearity, and robustness testing
• Support end-to-end product development from late-stage R&D through commercialization
• Lead or support product and process transfer to Manufacturing, including documentation and training
• Develop scalable and robust production processes for complex assay and reagent systems
• Troubleshoot process and QC issues during transfer and early manufacturing runs
• Collaborate with R&D, Manufacturing, QC, Quality, and Engineering teams
• Author SOPs, validation reports, and transfer documentation
• Lead or support root cause investigations and continuous improvement initiatives

Requirements

• Ph.D. in Biochemistry, Molecular Biology, Immunology, or a related discipline with 5+ years OR M.S. with 8+ years of relevant industry experience
• Deep expertise in QC method development, validation, and transfer to manufacturing
• Experience leading NPI and product transfer efforts f or commercially successful biotech tools or diagnostic products
• Strong background in assay development, reagent formulation, and analytical methods
• Experience with writing technical documentation including SOPs and validation reports
• Strong problem solving and troubleshooting skill s
• Experience with immunoassays (ELISA, MSD, Simoa ) and molecular assays (qPCR, ddPCR , NGS)
• Experience working in IVD or regulated environments (e.g., ISO 13485)
• Familiarity with statistical analysis tools such as JM P
• Understanding of manufacturing and scale-up considerations
• Demonstrated ability to work effectively as a team player, collaborating openly and constructively within cross-functional teams
• Experience with lyophilization or other freeze-drying methods
• Experience supporting process scale-up and early-stage manufacturing and QC
• Familiarity with automation or high-throughput workflows
• Programming or data analysis experience (Python or R)

Benefits

Additional Information

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. We are seeking a highly motivated Sr. Scientist I to join the Product Development team supporting New Product Introduction (NPI). This role focuses on downstream product development, including QC method development, analytical strategy, process optimization, and transfer of assays and reagents from R&D into Manufacturing. The Product Development team operates at the interface of R&D and Operations and is responsible for ensuring products are robust, scalable, and manufacturable.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at alamarbiosciences? Share your experience