Senior Scientist, IVD/CDx

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Company :
Guardant Health

Location :
Redwood City, California

Expiry Date :
Mon, 21 Dec 2020 23:59:59 GMT

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Description :
Job Details Full-timeEstimated: $91,000 – $120,000 a year4 hours ago Qualifications – Statistical analysis – FDA regulations – Assays – Communication skills – Writing skills – Doctoral degree Full Job Description Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers. Job Description As a Scientist, you will work with members within the team and interface with cross-functional project teams including quality, regulatory, clinical operations, research operations, and bioinformatics. The work will support analytical performance testing and clinical trials testing new targeted anti-cancer drugs. You will be hands on in the lab and be required to design and execute experiments related to liquid biopsy for the detection, treatment, and monitoring of all cancer types. The scientist will author study protocols and write technical reports for FDA submissions. The scientist will maintain electronic notebook and provide impeccable documentation to support quality control, regulatory affairs and clinical affairs in compliance with Quality Systems and Good Laboratory Practices. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly has an interest in our company and our products. Be able to work in a team environment and independently to develop, test and validate technologies for rare variant studies with next-generation sequencing Design study protocols, analyze results, and write reports for validation studies pertaining to IVD submissions and CDx tests with pharma partners Be hands on in the lab to prepare samples for verification and validation studies Be highly committed and deliver results in a fast-paced start-up environment Qualifications Experience working in a regulated environment, including developing IVD assays. Experience with CDx assay development preferred. Hands-on experience with Next-Generation Sequencing Technologies Strong documentation skills, especially writing study protocols and reports for FDA submissions. Experience with DOE, statistical analysis, and/or bioinformatics analysis of NGS data is a plus Excellent interdisciplinary communication skills required Good organization skills, and detailed orientated Self-driven and strong team player with proven track record Education: PhD in Molecular Biology, Genetics, Biochemistry or related field + 3 years industry experience in genomics or molecular biology developing genomic assays or equivalent degree and experience. itional Information All your information will be kept confidential according to EEO guidelines. Work Environment: 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. Show full job description Apply Now