Lead 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 Lead Reagent Manufacturing Associate is responsible for receiving, labeling, documenting, aliquoting of reagents used in the Clinical Laboratory and performing and documenting reagent qualification of incoming reagents. The Lead Reagent Manufacturing Associate will also assist with labeling and prepping of reagents for use on the automated instruments.

In addition to the primary role of Lead Reagent Manufacturing Associate, there will be a need to provide back-up support to Clinical Laboratory and Reagent Manufacturing Associates. The nature of the work requires excellent attention to detail, effective written and verbal communication skills, maintaining meticulous and organized records, the ability to multi-task and be flexible with tasks and schedules, and the ability to work independently in a team environment. The Lead Reagent Manufacturing Associate will comply with all applicable local, state and federal laboratory requirements.

The Lead Reagent Manufacturing Associate will interact with multiple teams including the Clinical Operations, Technology Development, Process Engineering, Supply Chain, and Quality groups.

Essential Duties and Responsibilities:

• Manage schedule for reagent manufacturing activities.
• Prepare and aliquot reagents required for performing and supporting (but not limited to) the Guardant360 test, pharma projects and external clients.
• Manufacture controls, reagents and kits required for performing and supporting (but not limited to) the Guardant360 test, pharma projects and external clients.
• Ensure all incoming reagents are processed and documented appropriately.
• Assist with managing and ensuring sufficient inventory of reagents used in the Clinical Operations laboratory.
• Coordinate reagent qualification activities with Clinical Operations personnel as necessary.
• Assist with reviewing and completing reagent qualification records.
• Coordinate and assist with reagent stability related activities.
• Coordinate and perform other miscellaneous laboratory duties as assigned and assist others as needed.
• Assist in the update and development of SOPs pertaining to reagent preparation and qualification.
• Communicate professionally and effectively with both internal and external personnel.
• Accurately perform molecular testing, using a variety of molecular biological techniques including next generation sequencing.
• Carry our QC/QA activities as part of the Quality program and commitment to patient safety.
• Participate in a variety of other essential laboratory activities, including reagent qualification, inventory management, procedure writing, inspection preparation, assay validation and investigation.
• Work schedule may be modified to meet operation requirements. Applicants must be flexible in work times
• Perform manufacturing and laboratory tests, procedures and analyses according to the laboratory’s 
standard operating procedures.
• Independently identify and troubleshoot problems that adversely affect the test performance.
• Perform, review and document laboratory quality control procedures.
• Document all corrective actions taken when test systems deviate from the laboratory’s 
established performance specifications.
• Perform and document routine preventive maintenance.
• Coordinate and assist with training of new laboratory personnel.
• Maintain sufficient inventory of laboratory supplies for daily operations and prepare reagents required for testing.
• Perform and document reagent qualification per the approved protocols.
• Perform annual review of Standard Operating Procedures.
• Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer.
• Participate in introduction of assay improvements, new assay configurations and validation.
• Perform other miscellaneous laboratory duties as assigned and assist others as time allows.

Qualifications

You are an ideal candidate if your qualifications inclu