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Scientist II - Technology Development

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Guardant Health

2024-11-05 01:37:27

Job location Palo Alto, California, United States

Job type: fulltime

Job industry: Science & Technology

Job description

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.

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