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||Redwood City, CA United States
|| Healthcare, Other, Information Technology, Installation, Maintenance, and Repair, Manufacturing and Production, Executive Management, Quality Control, Research & Development
Sr. Reagent Manufacturing Associate|
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.
The Senior Reagent Manufacturing Associate (SRMA) 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 charge 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
- Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred, or Associate degree / equivalent with 6+ years of experience in related field; OR High School Diploma with 10 years of experience in related field
- At least two years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred;
- Previous laboratory work experience preferred;
- Previous GMP laboratory work experience preferred;
- Ability to proactively communicate consistently, clearly, and honestly;
- Strong computing skills;
- 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; and
- Ability to work as part of a team.
- 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.
Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.
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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