Guardant Health
Scientist II - Technology Development
Guardant Health, Palo Alto, California, United States, 94306
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360, Guardant360 CDx, Guardant360 TissueNext, Guardant360 Response, and GuardantOMNI tests for advanced stage cancer patients, and Guardant Reveal for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield test, aims to address the needs of individuals eligible for cancer screening.
Job Description
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. 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). 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
Essential 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: 3-5 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.
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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. 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). 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
Essential 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: 3-5 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.
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