Senior Scientist I, Product Development

Duties and 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

Qualifications

• 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 for 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 skills
• 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 JMP
• Understanding of manufacturing and scale-up considerations
• Demonstrated ability to work effectively as a team player, collaborating openly and constructively within cross-functional teams