Scientist II - Technology Development
Company: Guardant Health
Location: Palo Alto
Posted on: October 18, 2024
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Job Description:
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 DescriptionThe
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 RoleThe 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
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Keywords: Guardant Health, Newark , Scientist II - Technology Development, IT / Software / Systems , Palo Alto, California
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