Senior Staff Scientist, Assay Development (Verification & Validation)
Senior Staff Scientist, Assay Development (Verification and Validation)
Location: San Diego, CA
Job Type: Full-Time
Salary: $175,000 - $190,000
Position Overview
We are seeking a Senior Staff Scientist to provide technical leadership for assay development under design control, with primary responsibility for analytical verification and validation of laboratory-developed tests (LDTs). This role will set validation strategy, translate product and clinical requirements into rigorous study plans and acceptance criteria, and ensure high-quality execution and documentation in a regulated environment.
The successful candidate will combine strategic scientific leadership with a willingness to perform hands-on laboratory work. The role partners closely with R&D, Product Management, Clinical, Lab Operations, Bioinformatics, Software, Quality, and Regulatory throughout the product development lifecycle, from design inputs through launch and post-launch improvements.
Key Responsibilities
- Own or co-own design verification and analytical validation strategy for assigned assays, including study design, sample and replicate plans, acceptance criteria, statistical approach, execution, data interpretation, and final reports.
- Design and lead analytical performance studies, as applicable, including accuracy, precision and reproducibility, analytical sensitivity and specificity, limit of detection, linearity or reportable range, interference, carryover, contamination risk, stability, robustness, and method or instrument equivalency.
- Partner with Product Management, Clinical, and Regulatory to translate intended use, product requirements, and clinical needs into clear, testable design inputs and verification or validation methods.
- Maintain traceability among user needs, design inputs, design outputs, risk controls, test methods, protocols, results, and design changes.
- Perform and/or directly supervise hands-on laboratory work for critical experiments, method...