Position Summary
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.
Duties and Respo nsibilities
- 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
- Experienceleading 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
