Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 29of the National Comprehensive Cancer Network centers.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development Team is seeking a highly motivated Scientist II to help test & validate novel technologies for rare variant studies with next-generation sequencing in a regulated environment. At Guardant, we leverage the most advanced technologies & work with leaders in many different fields to create the most impactful & meaningful technologies for cancer management.
As a Senior Scientist in the IVD team you will work within the team as well as collaborate cross-functionally with members of technology development, bioinformatics, quality control, regulatory affairs & clinical affairs. You will rise to the challenge of leading V&V studies (design, planning & execution) for our genotyping assay, providing technical reports to support FDA submissions. You are expected to divide your time between working in the lab & at the desk & guiding junior team members in their execution of NGS experiments to support IVD development. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking & most importantly, has an interest in our company & our products.
Essential Duties & Responsibilities:
- Work in a team environment & independently develop, test & validate technologies for early cancer detection studies with next-generation sequencing under design control
- Think creatively & apply knowledge to design validation experiments & analyze data for NGS applications in oncology diagnostics
- Document product development requirements & validation results
- Apply previous experience to author study protocols & write technical reports to support FDA submissions
- Be highly committed & deliver results in a fast-paced start-up environment
- Guide junior team members in their experimental execution & technical documentation.
- Experience with development under an FDA regulated environment for IVD product under design control
- Experience in development or optimization of nucleic acid technologies with a preference for sequencing-based genomic assays.
- Extensive experience in assay set up, reagent development & experimental design.
- Experience with data analysis, preferably NGS data
- Excellent interdisciplinary communication skills
- Good organization skills, detailed orientated mindset
- Consummate team player: demonstrated ability to contribute in an environment where numerous inputs are required to accomplish complex goals
- Curiosity & drive
- BA/BS with 15+ years of industry experience; MA/MS with 10+ years of industry experience, PhD with 8+ years of post PhD experience in Molecular Biology, Genetics, Biochemistry or related field.
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