Sr. Scientist, IVD

  • Full-time

Company Description

ABOUT OUR COMPANY

Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time and identifies associated treatment options. The assay is used by more than 6,000 oncologists and we partner with more than 50 biopharma companies.

Guardant Health raised over $550M from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed and Softbank, before having a successful IPO on NASDAQ in 2018. Guardant is led by a seasoned management team of thought leaders and successful serial entrepreneurs in next generation sequencing and rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.

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 Senior 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 Senior Scientist in the Technology Development Team you 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.

The position will work and interact 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. The scientist will author study protocols and write technical reports for FDA submissions.

You should be able to work in a team environment and independently to develop, test and validate technologies for rare variant studies with next-generation sequencing for IVD submissions. 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 candidate needs to be highly committed and deliver results in a fast-paced start-up environment

Essential Duties and Responsibilities:

  • Be able to work in a team environment and independently to develop, test and validate technologies for rare variant studies with next-generation sequencing
  • 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
  • Be highly committed and deliver results in a fast-paced start-up environment

Qualifications

  • PhD or M.S. in Molecular Biology, Genetics, Biochemistry or related field + 8 years industry experience in genomics or molecular biology developing genomic assays or equivalent experience.
  • Experience with development under an FDA regulated environment for IVD product under design control
  • Experience optimizing and developing assays for genomics applications
  • Comprehensive knowledge of sample preparation and sequencing technologies
  • Strong background in molecular biology
  • Experience in development or optimization of nucleic acid technologies with a strong preference related to sequencing-based genomic assays, preferably in regulated environments.
  • Extensive experience in assay set up, reagent development and experimental design.
  • Experience with data analysis, preferably NGS data
  • Excellent interdisciplinary communication skills required
  • Good organization skills, and detailed orientated
  • Self-driven and strong team player with proven track record

Additional Information

All your information will be kept confidential according to EEO guidelines.

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