Lead Reagent Manufacturing Associate - Guardant Health

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.

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.

You are an ideal candidate if your qualifications include: 

• Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field preferred.
• Ability to proactively communicate consistently, clearly, and honestly.
• Strong computing skills.
• Previous laboratory work experience required.
• Possess meticulous attention to detail.
• Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
• Able to integrate and apply feedback in a professional manner.
• 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.
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation.
• Repetitive manual pipetting may be necessary.
• Some lifting (up to 25 pounds) may be necessary

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $106,100 to $143,300. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com

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