Senior Staff Scientist, IVD Assay Development (LDT/Clinical NGS)
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- Experience with regulatory interactions and/or submissions support in partnership with RA/QA.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
