Manager, Technology Development
Employment Type: Full-Time
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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 7,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
The Screening Core is a dedicated organization inside of Guardant Health focused on the development and commercialization of the early cancer detection LUNAR portfolio. The Screening Core's singular focus on bringing our early cancer detection products to market allows us to act with the speed and urgency needed to achieve our ambitious goals and serve the millions of individuals who can benefit from early cancer detection
As a Manager in the TissueNext Technology Development team, you will work with members of the team and collaborate cross-functionally with members of technology development, bioinformatics, process engineering, automation, clinical development, and operations. You will be leading and participating in efforts to develop, implement, validate, and transfer assays to our clinical lab, distributing your time between experimental design and planning, management of reports, data analysis, and some hands-on work in the lab. You will lead and participate in teams supporting the development of IVD and LDT products. An ideal candidate would have experience with NGS assay development for automated platforms in a regulated environment. Preference is given to candidates with experience developing/optimizing oligonucleotide-based assay methodology including hybrid capture-related methods.
* Lead feasibility and development studies to create new NGS assays and workflows
* Ensure that developed NGS assays are both streamlined and robust
* Close collaborate with bioinformatics team to ensure data driven decision making approach for NGS assay development
* 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 both direct reports and mentor non-direct reports on the TissueNext Technology Development team
* 2-3 years in supervisory role
* 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 independently and collaboratively in a fast-paced environment and able to adapt to change
* Curiosity and drive
* Is passionate about mentoring and growing team members
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 input materials into NGS assay
PhD in Molecular Biology, Genetics, Biochemistry or related field and >5 years of relevant work experience
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.
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