Reagent Manufacturing Associate


GUARDANT HEALTH

Company 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.

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 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

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Job Description

The Reagent Manufacturing Associate (RMA) is responsible for manufacturing reagents, assembling kits, and qualification of assigned reagents following Good Manufacturing Practices (cGMP) and documenting events following current Good Documentation Practices (GDP).

Essential Duties and Responsibilities:

  • Manufacture reagents, assemble kits, and qualify assigned reagents according to Standard Operating Procedures (SOP’s)
  • Document reagent manufacturing activities following cGMP
  • Perform equipment maintenance according to the laboratory’s SOP’s
  • Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties
  • Clean racks and other laboratory supplies
  • Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
  • Perform clerical work and maintain Reagent Manufacturing and Quality Control documents as necessary
  • Assist with managing and ensuring sufficient inventory of reagents in the laboratories of Clinical Operations
  • Assist with troubleshooting of manufactured reagents
  • Assist in the revision and development of reagent manufacturing SOPs and forms
  • Participate in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are available for use at all times
  • Assist in inspection preparation activities as needed
  • Assist with the training of laboratory personnel on current and new procedures
  • Assist in evaluating RMAs for competency
  • Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer
  • Perform other duties as assigned

Qualifications

  • Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or a related science field preferred
  • At least one year of experience working in a highly complex and high volume clinical laboratory
  • Previous GMP laboratory work experience preferred
  • Ability to proactively communicate consistently, clearly, and honestly with both internal employees and customers
  • Able to integrate and apply feedback in a professional manner
  • The ability to work as part of a team

Work Environment

  • Hours and days may vary depending on operational needs;
  • Standing or sitting for long periods of time may be necessary;
  • Exposure to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation;
  • Repetitive manual pipetting may be necessary; and
  • Some lifting (up to 25 pounds) may be necessary.

Additional Information

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.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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