Senior Reagent Manufacturing Associate

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

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

Essential Duties and Responsibilities:

• Manufacture reagents, assemble kits, and qualify assigned reagents according to SOPs;
• Document reagent manufacturing activities following cGMP;
• Perform equipment maintenance according to the laboratory’s standard operating procedures;
• 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;
• Lead in the management of sufficient inventory of reagents in the laboratories of Clinical Operations;
• Lead in the troubleshooting of manufactured reagents;
• Lead in the revision and development of reagent manufacturing SOPs and forms;
• Lead 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;
• Participate in the inspection preparation activities as needed;
• Lead in the training of new and existing laboratory personnel on current and new procedures;
• Evaluate RMAs for competency;
• Lead in the introduction of manufacturing improvements or new manufacturing configurations;
• Revise and develop of Reagent Manufacturing SOPs and forms;
• Participate and lead various projects or studies;
• Participate in the development of the design and acceptance criteria for reagent manufacturing plans;
• Lead and document interdepartmental training on reagent manufacturing changes or improvements;
• May act as a team leader, when assigned, who will aid the Supervisors/Leads including but not limited to:
  • Oversee daily operations of the Reagent Manufacturing department including but not limited to scheduling, troubleshooting and resolving technical and non-technical issues
  • Lead in team meetings;
  • Provide daily supervision of RMAs as needed;
  • Assist in administrative duties including but not limited to review of documents and forms;
  • Take ownership of shift communication if supervisors/leads are not present; and
  • Provide updates to supervisors/lead regarding any issues.
• Perform other duties as assigned; and
• Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer.

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.

Qualifications

• High School Diploma with 10 years of experience in related field; OR
• Minimum of Associate degree or equivalent with 8 years of experience in related field; OR
• Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred;
• At least two years of Guardant Health Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred;
• Previous laboratory work experience required;
• Previous GMP laboratory work experience required;
• Ability to proactively communicate consistently, clearly, and honestly;
• Strong computing skills;
• Strong communicator with ability to maintain open communication with internal employees, managers and custom