Job Description

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 transfer of the product to the Guardant health clinical laboratory and subsequent launch. The current focus of the role will be supporting regulatory submissions to both FDA and ex-US regulatory agencies as subject matter experts in analytical and clinical validation studies. However, the full scope additionally includes LDT and RUO product development and validation utilizing standard design control processes.

About the Role:

The Scientist II will support assay development and validation with the goal of helping launch new products and companion diagnostics. The Scientist II 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 II 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 .
• 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).
• 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 IVD 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.

Qualifications

• Degree in Molecular Biology, Genetics, Biochemistry, or related field. PhD preferred. Masters and Bachelors with a track record of performance in Scientist roles will be considered.
• Post-graduate industry experience in genomics or molecular biology.
  • Successful candidates have the following experience (assuming PhD)
    • Scientist II: 2-5 years
• Experience with assay development. Next-generation sequencing-based assays preferred.
• Experience with assay validation. IVD validation and regulatory defense preferred.
• Experience with product development, including technology transfer and operational troubleshooting
• Strong documentation skills, especially writing study protocols and reports.
• Excellent interdisciplinary communication skills.
• Detail-oriented with good organization.
• Self-driven and a strong team player.

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.

Additional Information

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $104,800 to $141,500. 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 toPeopleteam@guardanthealth.com

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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