Manager, Clinical Operations

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. 

About the Role:

The Manager of Clinical Operations is responsible for the technical operations of the Clinical Laboratory. The Manager monitors patient and quality control testing results, writes and reviews standard operating procedures, addresses technical issues and takes remedial action when needed. The Manager ensures laboratory staff are correctly trained on all processes and supervises both licensed and unlicensed laboratory team members. As a leader of the Clinical Operations function as well, the Manager will be responsible for supervision of the laboratory staff. The Manager demonstrates good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure and the ability to communicate effectively across levels and functions. The Manager will ensure that the Clinical Lab team adheres to CLIA and CAP standards. The Manager complies with all applicable local, state and federal laboratory requirements and operates under the direction of the Laboratory Director and Director of Clinical Operations.

 Essential Duties and Responsibilities:

• Accurately monitor molecular testing
• Conduct and oversee daily quantitation and 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 and investigation
• Work with the Clinical Laboratory General Supervisor, Technical Supervisor and the Accessioning Supervisor on the laboratory’s quality control and quality assurance procedures, technical troubleshooting and improvement procedures, reagent manufacturing, and training and education programs
• Review and document routine preventive maintenance and independently identify and troubleshoot highly complex problems that adversely affect test performance
• Identify root cause and document all corrective actions taken with test systems
• Oversee training and competency of new and existing laboratory personnel
• Manage stability study, validation protocols, and other process improvement and new assay projects
• Participate in audits and inspections
• Perform biennial review of Standard Operating Procedures
• Participate in introduction of assay improvements, new assay configurations and validation
• Support the Clinical Operations team and 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
• Report all concerns of test quality and/or safety to the Laboratory Director or Safety Officer.

Essential Qualifications:

• Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field
• At least eight years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred
• At least two years of supervisory experience preferred
• Working knowledge of local, state, and federal laboratory regulations
• Working knowledge of FDA QSR and ISO 13485 requirements a plus
• 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
• Strong project management abilities.

Work Environments:

• Hours and 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 and instruments with moving parts, heating or freezing elements, and high-speed centrifugation;
• May be required to lift routine office supplies and use office equipment;
• Majority of the work is performed in a desk/office environment; and
• Ability to sit for extended periods of time.

AI & Digital Fluency

• Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Hybrid Work Model:This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies.  Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility willbe required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients. 

Employee may be required to lift routine office supplies and use officeequipment. 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 laboratoryenvironment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

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.

Please visit our career page at: http://www.guardanthealth.com/jobs/