Principal Scientist, Translational Assay Development

Key Responsibilities

• Lead development of quantitative assays supporting oncology, infectious disease, neurodegeneration, and other diagnostic applications.
• Design, optimize, and troubleshoot assays from advanced feasibility through analytical validation.
• Develop assays using proteins, antibodies, aptamers, extracellular vesicles, nucleic acids, and other biological analytes.
• Establish and run hands-on assay workflows that are reproducible, scalable, and compatible with product development.
• Develop reagent strategies, calibration methods, controls, reference materials, and quality metrics.
• Design and execute analytical validation studies following CLSI guidance and industry best practices.
• Prepare validation reports suitable for regulatory documentation and Design History Files.
• Design statistically rigorous experiments that efficiently optimize assay performance, applying Design of Experiments (DOE) principles where appropriate.
• Analyze data using statistical software to establish acceptance criteria and performance specifications.
• Partner with Engineering to optimize instrument performance.
• Support Design Verification and Design Transfer activities.
• Participate in Risk Analysis and Design Control activities.
• Mentor scientists and research associates.

Experience, Education, And Skills Required

• PhD in Biochemistry, Molecular Biology, Bioengineering, Biomedical Engineering, Immunology, Analytical Chemistry, or a related discipline.
• Typically requires a PhD with 8+ years of relevant industry experience, an MS with 12+ years, or a BS with 15+ years.
• Experience developing diagnostic products in one or more of the following areas: in vitro diagnostics (IVD), liquid biopsy, point-of-care diagnostics, proteomics, extracellular vesicles, aptamer technologies, oncology diagnostics, or infectious disease diagnostics.
• A demonstrated track record of developing quantitative assays intended for clinical or diagnostic use.
• Hands-on experience designing and executing analytical validation studies.
• Experience working in regulated diagnostic environments is strongly preferred.
• Comfort learning and using modern productivity platforms, AI-based tools, scheduling systems, and workflow technologies to improve operational efficiency.
• A proactive, resourceful, and customer-service-oriented approach, with a natural positive energy that supports an efficient work environment.
• Ability to multi-task and work in a fast-paced environment, managing competing priorities while maintaining composure.
• Sound judgment and discretion when handling confidential materials or information.
• Ability to work independently and as part of a team, with strong attention to detail and organizational skills.