Senior Staff Scientist, IVD Assay Development (LDT/Clinical NGS)
Senior Staff Scientist, IVD Assay Development (LDT/Clinical NGS)
Location: San Diego, CA
Job Type: Full-Time
About Us
We are a venture-backed, stealth-stage biotechnology company based in San Diego, focused on developing novel technologies that will redefine how disease is detected, characterized, and managed with a novel approach. Our mission is to fundamentally transform healthcare through a convergence of innovation across multiple scientific disciplines.
Founded by industry veterans with decades of experience in life sciences, our leadership team brings a proven track record of translating scientific insight into successful commercial products. Our investors include some of the most respected names in healthcare and deep tech.
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.
This role is expected to set technical direction, drive decision-making under design control, and lead through influence across a matrixed organization.
Key Responsibilities
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.
Qualifications
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.
Why Join Us
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.
