Staff Scientist, IVD

Job Description

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 Staff Scientist to help test and validate novel technologies for rare variant studies with next-generation sequencing in a regulated environment. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management.

As a Staff 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 and clinical affairs. You will rise to the challenge of leading V&V studies (design, planning and execution) for our genotyping assay, providing technical reports to support FDA submissions. You are expected to divide your time between working in the lab and at the desk and leading 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 and most importantly, has an interest in our company and our products.

• Work in a team environment and independently develop, test and validate technologies for early cancer detection studies with next-generation sequencing under design control
• Think creatively and apply knowledge to design validation experiments and analyze data for NGS applications in oncology diagnostics
• Document product development requirements and validation results
• Apply previous experience to author study protocols and write technical reports to support FDA submissions
• Be highly committed and deliver results in a fast-paced start-up environment
• Lead junior team members in their experimental execution and 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 and experimental design.
• Experience with data analysis, preferably NGS data
• Experience leading small teams
• 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 and 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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