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. Guardant Reveal is a minimal residual disease test, launched this year to help manage the treatment of early-stage colorectal cancer and we are seeking a Clinical Laboratory Scientist Lead who will be responsible for building and supporting the production operations.
The Clinical Laboratory Scientist Lead is responsible for performing high complexity laboratory testing on patient specimens, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently in a team environment.
Essential Duties and 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 and resolving technical and non-technical high complexity problems;
- Provide direct supervision of the work of unlicensed laboratory personnel during the analytical phase of testing;
- Independently identify and troubleshoot high complexity problems that adversely affect test performance;
- Perform administrative duties including but not limited to writing employee performance evaluations, writing and reviewing SOPs, protocols, QC forms, and equipment maintenance forms as assigned;
- Coach and mentor CLSs and CLAs including but not limited to providing guidance and constructive feedback and assisting with the development of the troubleshooting and judgment skills;
- Manage the testing and validation of new laboratory equipment and procedures;
- Participate in introduction of assay improvements, new assay configurations and validation;
- Participate in the inspection preparation activities as needed;
- Perform laboratory tests, procedures, and analyses according to the laboratory's standard operating procedures as needed;
- Perform, review and 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 and training of new procedures with existing personnel;
- Participate in quality assurance activities;
- Effectively communicate technical information to technical and non-technical audiences;
- Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and communicating these to the appropriate management representatives as necessary for resolution;
- Perform other laboratory duties as assigned;
- Perform and 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 license pursuant to Division 2, Chapter 3 of the California Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to Division 2, Chapter 5 of the California Business and 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 and volume laboratory experience preferred;
- At least two years of management experience preferred;
- Laboratory experience within the last year preferred;
- Experience in molecular biology techniques preferred;
- Strong working knowledge of local, state, and federal laboratory regulations;
- Able to integrate and apply feedback in a professional manner;
- Ability to manage daily test processing needs with high emphasis on quality;
- Ability to analyze and problem solve basic issues that impact test performance;
- Ability to work as part of a team;
- Strong computer and automation skills;
- Ability to proactively communicate consistently, clearly, and honestly;
- Outstanding professionalism, leadership, and communications skills;
- Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed;
- Ability to provide direct supervision to laboratory personnel; and
- Strong project management abilities.
- Hours and days may vary (including conversion to weekend shifts) 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; and
- Some lifting (up to 25 pounds) may be necessary.
Delegated Duties and Responsibilities:
- The Clinical Laboratory Scientist Lead is responsible for day-to-day oversight of the laboratory operation and personnel performing testing and reporting test results and 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 and 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 and 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 and 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 and the test system is properly functioning;
- Provide orientation to all testing personnel;
- Evaluate and 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 and the participation is documented; and
- Report all concerns of test quality and/or safety to the Laboratory Director, Technical Supervisor or Safety Officer.
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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