Senior Scientist- Technology Development

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Department Summary

The Technology Development Department is responsible for developing, validating, and implementing the tests used by Guardant Health for cancer detection. This role will be within the Product Development wing of Technology Development. The Product Development group is primarily responsible for late-stage assay development, including interfacing with early-stage assay development to finalize the assay, verifying and validating the product, and supporting design transfer to the Guardant health clinical laboratory and subsequent launch. This role will be supporting regulatory submissions to both FDA and ex-US regulatory agencies as a subject matter expert in analytical and clinical validation studies. The role will additionally include LDT and RUO product development and validation utilizing standard design control processes.

About the Role

The Senior Scientist will support assay development and validation with the goal of helping launch new products. The scientist will lead analytical performance testing, support clinical validation studies, and interface with lab directors, other technology development staff, bioinformatics, engineering, quality, regulatory, and product groups to support product development. The scientist will have opportunities to assist in the product development, transfer of assay to the clinical laboratory and post-launch support of the products. 

Essential Duties and Responsibilities

• Design, execute, and analyze validation studies, ensuring clear and comprehensive documentation of results in compliance with Quality Systems and Good Laboratory Practices.
• Perform hands-on laboratory work, including the development, optimization, and troubleshooting of assays, devices, or technologies.
• Lead or contribute to the preparation of technical documentation and regulatory submissions, including device master records, risk assessments, and technical dossiers for regulatory bodies (e.g., FDA, CE marking, CAP/CLIA certifications, NYSDOH).
• Manage project timelines, resources, and tasks, coordinating and presenting to both internal and external stakeholders to ensure timely and successful project execution.
• Stay current with advances in NGS diagnostic technologies and regulatory guidelines, integrating best practices into product development and validation strategies.
• Ensure compliance with all relevant safety, ethical, and quality standards during product development and testing phases, especially as it relates to data integrity.
• Provide mentorship and technical guidance to junior staff or cross-functional team members as needed.

• Advanced degree in Molecular Biology, Genetics, Biochemistry, or related field (PhD preferred).
• PhD with 5–8 years of industry experience
• MS with 10–12 years of industry experience
• Strong background in assay development; NGS-based assays highly preferred
• Experience with assay validation (IVD validation and regulatory defense a plus)
• Product development expertise, including technology transfer and troubleshooting
• Excellent documentation skills (study protocols, technical reports)
• Strong communication and collaboration skills
• Detail-oriented, organized, and self-driven

Preferred Qualifications:

• Familiarity with statistical analysis and bioinformatics analysis of NGS data desired.
• Quick learner who enjoys multi-tasking.
• Interest in oncology diagnostics and patient care.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $110,160 to $151,470. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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Please visit our career page at: http://www.guardanthealth.com/jobs/