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Guardant Health // rare-cell diagnostics
, Full Time       Posted: Friday, February 28, 2020
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Company Description

Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics.The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers

Job Description

The Clinical Laboratory General Supervisor (GS) is responsible for the general supervision of personnel & the daily operations in the Clinical Laboratory. The GS will often be the first point of contact for CLSs & Clinical Laboratory Associates (CLA) during laboratory processing & will provide guidance while troubleshooting high complexity technical & non-technical problems. The GS must also act as a liaison between the CLSs, CLAs, Technical Supervisor, Quality Manager & Laboratory Director. The GS will also be involved with scheduling, troubleshooting high complexity technical & non-technical problems, coaching & mentoring the laboratory staff, building effective teams, managing projects & meeting project deliverables, & understanding & implementing laboratory goals.Given the wide variety of tasks involved in this position, the GS must demonstrate the ability to analyze complex issues & make sound decisions in a timely manner, commitment to helping & motivating employees, the ability to respond to difficult issues quickly, fairly, & ethically, outstanding organizational skills, the ability to respond to change with flexibility & to adapt quickly to evolving circumstances, excellent communication skills including utilizing various communication channels, proactively communicating team goals & priorities clearly, openly & objectively, & communicating changes, issues, & challenges in all directions of the organization.

The nature of the work requires excellent attention to detail, effective written & verbal communication skills, the ability to multitask & be flexible with tasks & schedules, & the ability to work independently in a team environment.

Essential Duties & Responsibilities:

  • Provide day-to-day supervision of laboratory personnel;
  • Be responsible for the daily operations of the laboratory including but not limited to scheduling, independently troubleshooting & resolving technical & non-technical high complexity problems;
  • Provide direct supervision of the work of unlicensed laboratory personnel during the analytical phase of testing;
  • Independently identify & troubleshoot high complexity problems that adversely affect test performance;
  • Perform administrative duties including but not limited to writing employee performance evaluations, writing & reviewing SOPs, protocols, QC forms, & equipment maintenance forms as assigned;
  • Coach & mentor CLSs & CLAs including but not limited to providing guidance & constructive feedback & assisting with the development of the troubleshooting & judgment skills;
  • Manage the testing & validation of new laboratory equipment & procedures;
  • Participate in introduction of assay improvements, new assay configurations & validation;
  • Participate in the inspection preparation activities as needed;
  • Perform laboratory tests, procedures, & analyses according to the laboratory's standard operating procedures as needed;
  • Perform, review & document laboratory quality control procedures, as needed;
  • Document all corrective actions taken when test systems deviate from the established performance specifications as needed;
  • Assist with the training of new laboratory personnel & training of new procedures with existing personnel;
  • Participate in quality assurance activities;
  • Effectively communicate technical information to technical & non-technical audiences;
  • Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, & communicating these to the appropriate management representatives as necessary for resolution;
  • Perform other laboratory duties as assigned;
  • Perform & document reagent qualification per the approved protocols as needed;
  • Perform biennial review of Standard Operating Procedures; and
  • Report all concerns of test quality and/or safety to the Technical Supervisor, Laboratory Director or Safety Officer.

  • Must possess an active, valid CLS or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California CLS or CGMBS licensepursuant to Division 2, Chapter 3 of the California Business & Professions Code or to practice medicine, osteopathy or podiatry pursuant to Division 2, Chapter 5 of the California Business & Professions Code appropriate to the specialty or specialties they are performing;
  • Must fulfill requirements stated in Title 17 California Code of Regulations Section 1036.1;
  • Must fulfill requirements stated in 42 CFR 493.1461 or 493.1462;
  • Must fulfill requirements stated as described in 10 NYYCRR Parts 58-1.4;
  • Must fulfill requirements stated in 28 Pennsylvania Code 5.23;
  • Must fulfill requirements stated in the College of American Pathologists Molecular Pathology Checklist;
  • Bachelor's degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field;
  • At least six years of Guardant Health Clinical Laboratory experience or equivalent high complexity & volume laboratory experience preferred;
  • At least two years of supervisory experience preferred;
  • Laboratory experience within the last year preferred;
  • Experience in molecular biology techniques preferred;
  • Strong working knowledge of local, state, & federal laboratory regulations;
  • Able to integrate & apply feedback in a professional manner;
  • Ability to manage daily test processing needs with high emphasis on quality;
  • Ability to analyze & problem solve basic issues that impact test performance;
  • Ability to work as part of a team;
  • Strong computer & automation skills;
  • Ability to proactively communicate consistently, clearly, & honestly;
  • Outstanding professionalism, leadership, & communications skills;
  • Strong communicator with ability to maintain open communication with internal employees, managers & customers as needed;
  • Ability to provide direct supervision to laboratory personnel; and
  • Strong project management abilities.

Work Environment:

  • Hours & 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 & instruments with moving parts, heating or freezing elements, & high-speed centrifugation;
  • Repetitive manual pipetting may be necessary; and
  • Some lifting (up to 25 pounds) may be necessary.

Delegated Duties & Responsibilities:

The General Supervisor is responsible for day-to-day supervision or oversight of the laboratory operation & personnel performing testing & reporting test results & must:

  • Be accessible to testing personnel at all times testing is performed by providing on-site consultation to resolve technical problems in accordance with policies & procedures established either by the Laboratory Director or Technical Supervisor;
  • Ensure a general supervisor is on the laboratory premises during all hours in which tests are performed on samples originating from New York & Pennsylvania;
  • Be onsite to provide direct supervision when high complexity testing is performed by any qualified individuals;
  • Be responsible for providing day-to-day supervision of high complexity test performance by testing personnel;
  • Be responsible for monitoring test analyses & specimen examinations to ensure that acceptable levels of analytic performance are maintained;
  • Assure that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
  • Ensure that patient test results are not reported until all corrective actions have been taken & the test system is properly functioning;
  • Provide orientation to all testing personnel;
  • Evaluate & document the performance of all testing personnel on an annual basis;
  • Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
  • Ensure that technical staff participate in at least twelve continuing education hours commensurate with their duties per year & the participation is documented; and
  • Report all concerns of test quality and/or safety to the Laboratory Director, Technical Supervisor or Safety Officer.

Additional Information

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 & 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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To learn more about the information collected when you apply for a position at Guardant Health & how it is used, please review ourPrivacy Notice for Job Applicants.


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