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Manager of Process Development & Technology Transfer

Company: Guardant Health, Inc.
Location: Redwood City
Posted on: May 3, 2021

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. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360, Guardant360 CDx and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of 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.

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

Requirements:

  • 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.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

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Keywords: Guardant Health, Inc., Redwood City , Manager of Process Development & Technology Transfer, Other , Redwood City, California

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