Lead Clinical Laboratory Scientist, MRD (2nd Shift, Tues-Sat)

Job Description

The

• 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.

Qualifications

• 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 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.

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 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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