Company Description|Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Manager of Clinical Operations is responsible for the technical operations of the
Clinical Laboratory. The Manager monitors patient & quality control testing results,
writes & reviews standard operating procedures, addresses technical issues & takes
remedial action when needed. The Manager ensures laboratory staff are correctly trained
on all processes & supervises both licensed & unlicensed laboratory team members. As
a leader of the Clinical Operations functions as well, the Manager will be responsible for
supervision of the laboratory staff. The Manager demonstrates good judgment, sound
analysis & decision making, the ability to remain professional & composed under
pressure & the ability to communicate effectively across levels & functions. The
Manager will ensure that the Clinical Lab team adheres to CLIA & CAP standards. The
Manager complies with all applicable local, state & federal laboratory requirements and
operates under the direction of the Laboratory Director & Director of Clinical Operations.
- Accurately monitor molecular testing;
- Conduct & oversee daily quantitation & qualification assessment of molecular data generated during testing;
- Lead a variety of other essential laboratory activities, including reagent qualification, inventory management, procedure writing, inspection preparation, assay validation & investigation;
- Work with the Clinical Laboratory General Supervisor, Technical Supervisor & the Accessioning Supervisor on the laboratory's quality control & quality assurance procedures, technical troubleshooting & improvement procedures, reagent manufacturing, & training & education programs;
- Review & document routine preventive maintenance & independently identify & troubleshoot highly complex problems that adversely affect test performance;
- Identify root cause & document all corrective actions taken with test systems;
- Oversee training & competency of new & existing laboratory personnel;
- Manage stability study, validation protocols, & other process improvement & new assay projects;
- Participate in audits & inspections;
- Perform biennial review of Standard Operating Procedures;
- Participate in introduction of assay improvements, new assay configurations & validation;
- Support the Clinical Operations team & be responsible for the daily operations of the laboratory including but not limited to scheduling, independently troubleshooting & resolving technical & non-technical high complexity problems; and
- Report all concerns of test quality and/or safety to the Laboratory Director or Safety Officer.
- Bachelor's degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field;
- At least eight years of Guardant Health Clinical Laboratory experience or equivalent high complexity & volume laboratory experience preferred;
- At least two years of supervisory experience preferred;
- Working knowledge of local, state, & federal laboratory regulations;
- Working knowledge of FDA QSR & ISO 13485 requirements a plus;
- 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.
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.
Please visit our career page at:http://www.guardanthealth.com/jobs/
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