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.

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.