Manager, Technology Development- TissueNext

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.

As a Manager in the TissueNext Technology Development team, you will lead a team to develop, implement, and validate complex, automated NGS clinical tests. You will be directly responsible for leading a team of research associates and scientists and leading all aspects of assay development including concepts, requirements, experimental design and planning, overseeing execution of experiments, data analysis, management of direct reports, and occasional hands-on work in the lab.

You will leverage an understanding of NGS data analysis to guide assay development as well as work with members of the team and collaborate cross-functionally with members of technology, bioinformatics, process engineering, software, clinical development, and operations teams.

Duties:

• Lead feasibility and development studies to create new clinical NGS assays and workflows
• Ensure that developed NGS assays meet product requirements and project timelines
• Closely collaborate with bioinformatics team to ensure data driven decision making approach for NGS assay development
• Partner with process engineering to automated robust NGS workflows
• Collaborate cross-functionally to facilitate the effective transfer of methods and processes to the CLIA lab
• Identify areas for improvement in assay work stream and propose and implement solutions
• Ensure all work is performed and documented in compliance with applicable regulatory and quality practices (CLIA/CAP, IVD (Design Control), ISO13485)
• Present data, proposals, and progress in various forums and to technical and non-technical audiences
• Manage direct reports and are directly responsibility for their growth

Qualifications:

• Strong foundation in molecular biology techniques including sample preparation for NGS
• Quantitative/analytical mindset - ability to segment complex problems into fundamental parts/basic principles, develop models and experimental tests for those models, and synthesize results into actionable solutions
• Experience with NGS data analysis tools (Python, R, IGV, etc.) with a strength in generating key insight from NGS data sets
• Demonstrated ability to organize, document and communicate scientific data
• Consummate team player: demonstrated ability to contribute in an environment where numerous contributions are required to accomplish complex goals
• Enjoy working collaboratively in a fast-paced, startup environment and able to adapt to change
• Is passionate about mentoring and growing team members
• 2-3 years in supervisory role
• Experience in the following areas is highly desirable:
  • Product development in a regulated environment
  • Experience with assay development for automated liquid handling platforms
  • Experience optimizing/developing oligonucleotide- and hybrid capture- based technologies.
  • Experience with a variety of different NGS methods and different analytes

Education:
PhD in Molecular Biology, Genetics, Biochemistry or related field and >8 years of relevant work experience

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.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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

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