Senior Staff Scientist, Assay Development (Verification and Validation)Location: San Diego, CA
Job Type: Full-Time
Salary: $175,000 - $190,000
Position OverviewWe 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 troubleshooting, and analytical validation studies.
- Author and review high-quality development and quality documentation, including study plans, protocols, reports, SOPs, work instructions, technical assessments, deviations, investigations, and change-control records.
- Communicate technical risks, tradeoffs, recommendations, and decisions clearly to cross-functional stakeholders and company leadership.
- Mentor junior scientists and establish high standards for experimental design, data integrity, documentation quality, and scientific communication.
QualificationsRequired:
- Degree in Molecular Biology, Biochemistry, Biotechnology, or related discipline.
- PhD with 10+ years of relevant industry experience or BS/MS with 15+ years of relevant industry experience.
- Demonstrated experience advancing LDT products from development through analytical validation, transfer, and launch.
- Substantial hands-on experience designing, executing, analyzing, and documenting analytical verification and validation studies for LDTs.
- Strong working knowledge of design controls, risk management, cGMP principles, and ISO 13485-aligned quality systems.
- Experience working in a regulated clinical laboratory and/or diagnostic product-development environment, such as CLIA, CAP, or New York State-regulated laboratories.
- Proven ability to generate and critically review high-quality technical and quality documentation suitable for audits, inspections, and regulatory review.
- Demonstrated ability to lead complex cross-functional initiatives and influence scientific, engineering, operational, quality, and regulatory stakeholders without direct authority.
- Strong scientific judgment, structured problem-solving skills, and clear written and verbal communication.
- Willingness and ability to perform hands-on laboratory work as program needs require.
- Demonstrated commitment to mentoring and developing scientists.
Preferred:
- Experience with high-complexity NGS assays.
- Experience supporting regulatory interactions, submissions, or reimbursement evidence packages, including MolDX, in partnership with Quality and Regulatory.
- Experience with automated or high-throughput assay workflows and transfer into regulated clinical laboratory operations.
- Familiarity with CLSI guidance and statistical methods used in analytical performance evaluation.
