We are seeking a highly motivated Senior Scientist I to join the Product Development team and support New Product Introduction (NPI). This role focuses on downstream product development, including QC method development, analytical strategy, verification and validation (V&V), and technology transfer of assays and reagents from R&D to Manufacturing. Working at the interface of R&D and Operations, the Product Development team ensures that products are robust, scalable, and suitable for reliable manufacturing and commercialization.
Duties and Responsibilities
- Design and execute verification and validation (V&V) studies to assess precision, sensitivity, linearity, robustness, and other key 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, including technical documentation, process implementation, and training.
- Collaborate cross-functionally with R&D, Manufacturing, QC, Quality, and Engineering teams to ensure successful product development and transfer.
- Lead or support root cause investigations and continuous improvement initiatives to improve product quality, process robustness, and manufacturing efficiency.
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.
The base salary range for this full-time position is $150,000 - $165,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.