Full Job Description
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. 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 program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with 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.
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 Manager of Process Development and Technology Transfer to lead successful technical delivery of IVD quality products related to liquid biopsy sequencing assays for the early detection, treatment, and monitoring of all cancer types. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful, meaningful, and scalable technologies for cancer management.
As the Manager of Process Development and Technology Transfer team, you will lead the R&D team responsible for supporting launched genotyping products and transferring QC methods and reagent process to the operations lab. You will work hand-in-hand with assay and automation development teams across products. In this role, you’ll have the opportunity to collaborate with industry and thought leaders in assay development, bioinformatics, quality assurance, and regulatory affairs. You will lead and participate in teams supporting IVD and LDT products throughout the development life-cycle, working under design control in accordance with applicable regulatory requirements (FDA, ISO13485).
We’ll look to you to optimize complex problems at the interface of molecular biology, manufacturing, laboratory automation, quality assurance, regulatory affairs and operations.
Lead a team of scientists and research associates to develop and transfer reagent formulation and qualification processes
Critically assess experimental data, provide guidance on interpretation of results, and ensure data quality and integrity
Acts as a mentor for junior staff, provide coaching and emphasize best practices
Introduce new technology to enhance workflow and capabilities
Provide technical leadership for the timely resolution of complex process issues
Ensure that required documentation is created per Quality and Regulatory requirements
Lead transfer of processes to Operations
Provide technical guidance on the development of new reagent specifications and qualification methods
Support Process Validations
Generate and/or review process risk assessments and/or process FMEAs and develop risk mitigation plans
Serve as key technical liaison for reagent vendors and contract manufacturers
Ph.D. in Molecular Biology, Biochemistry, or related scientific discipline.
A minimum of 5 years leading and providing technical guidance to an IVD development team.
Experience with NGS technologies and sequencing data analysis is highly preferred
Knowledge of 21 CFR part 820 and ISO13485 is required
Strong technical and problem solving skills and deep knowledge of molecular biology and biochemistry are a must
A good sense of humor is mandatory
A strong drive to deliver high quality results and meet aggressive timelines is required
Effective verbal and written communication skills are essential
Ability to interface and drive change from team members of various disciplines: Development, Marketing, Supply Chain Management, Product Management, Regulatory, Quality Assurance, and Operations
Ability to take initiative and maintain quality standards in an environment of fast-paced innovation
A driven, flexible, goal-oriented leader and collaborative team member
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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