Senior Staff Scientist, IVD Assay Development; LDT​/Clinical NGS

Position Overview

We are seeking a Senior Staff Scientist role responsible for providing technical leadership and hands‑on execution across the full lifecycle of development, from early product definition through verification/validation, design transfer, and launch. This position partners broadly cross‑functionally with all areas at the company to deliver compliant, scalable lab‑developed tests in a regulated environment, with strong emphasis on analytical rigor, documentation quality, and cross‑functional alignment.

Location:

San Diego, CA

Job Type: Full‑Time

$175,000–$190,000

• Lead and drive assay/workflow development under design control, from design inputs through design outputs, verification/validation readiness, and launch.
• Translate product and clinical needs into design inputs, acceptance criteria, and test methods; ensure traceability across development artifacts and changes.
• Design and execute formal assay development studies.
• Develop assay QC metrics and process monitoring KPIs.
• Serve as technical lead for Analytical Validation (AV) and verification activities including study strategy, protocol authoring, execution oversight, data analysis, and final reporting.
• Collaborate closely with partners to ensure the assay system is scalable, manufacturable, and operationally robust.
• Operate effectively in a regulated lab environment, supporting quality events as needed while maintaining scientific momentum.
• Perform and/or directly supervise hands‑on laboratory work for critical experiments and root‑cause investigations.
• Mentor junior scientists and set expectations for experimental rigor, documentation quality, and effective cross‑functional communication.

Required:

• 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 delivering from product development to launch in a regulated environment (e.g., CAP/CLIA).
• Hands‑on experience executing and documenting analytical validation of LDTs.
• Strong working knowledge of Design Controls; able to generate and review high‑quality development and quality documentation.
• Proven ability to work highly cross‑functionally with internal stakeholders.
• Demonstrated ability to mentor and technically lead junior scientists and influence cross‑functional teams without direct authority.

Preferred:

• Experience with regulatory interactions and/or submissions support in partnership with RA/QA.

• Influence the foundational technologies and strategies of a company poised to shape the future of healthcare.
• Work in a dynamic, collaborative environment where innovation and scientific rigor are deeply valued.
• Join a seasoned and multidisciplinary team tackling high‑impact.
• Competitive compensation and equity package, comprehensive benefits, and flexibility to support work‑life integration.

We are an equal opportunity employer. We thrive on diversity and collaboration. Compensation Range: $175K – $190K