Manager, Clinical Operations

Guardant Health•Redwood City, CA

1d•Hybrid

About The Position

The Manager of Clinical Operations is responsible for the technical operations of Guardant Health’s Clinical Laboratory and supervises laboratory staff, including licensed and unlicensed team members. 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 role ensures laboratory staff are trained on processes and that the Clinical Lab team adheres to CLIA and CAP standards. The Manager complies with applicable local, state, and federal laboratory requirements and operates under the direction of the Laboratory Director and Director of Clinical Operations. The Manager is expected to exercise sound judgment, analysis, and decision-making; remain professional and composed under pressure; and communicate effectively across levels and functions. Responsibilities include managing daily laboratory operations, maintaining testing quality and safety, overseeing training and competency, and contributing to assay validations and process improvement projects. The role may involve variable hours and days depending on operational needs. For employees eligible for hybrid work under management direction and company policies, Guardant’s hybrid model includes scheduled in-person collaboration and work-from-home days. U.S. employees living within 50 miles of a Guardant facility are required to work onsite Mondays, Tuesdays, and Thursdays.

Requirements

Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science, or a related field.
Working knowledge of local, state, and federal laboratory regulations.
Ability to integrate and apply feedback professionally.
Ability to manage daily test-processing needs with a strong emphasis on quality.
Ability to analyze and solve basic issues that affect test performance.
Ability to work as part of a team.
Strong computer and automation skills.
Ability to communicate proactively, consistently, clearly, and honestly.
Professionalism, leadership, and communication skills.
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.

Nice To Haves

At least eight years of clinical laboratory experience or equivalent high-complexity and high-volume laboratory experience.
At least two years of supervisory experience.
Working knowledge of FDA QSR and ISO 13485 requirements.
Laboratory experience within the last year.
Experience with molecular biology techniques.

Responsibilities

Accurately monitor molecular testing.
Conduct and oversee daily quantitation and qualification assessment of molecular data generated during testing.
Lead laboratory activities including reagent qualification, inventory management, procedure writing, inspection preparation, assay validation, and investigations.
Work with the Clinical Laboratory General Supervisor, Technical Supervisor, and Accessioning Supervisor on 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 causes and document corrective actions taken with test systems.
Oversee training and competency of new and existing laboratory personnel.
Manage stability studies, validation protocols, process-improvement projects, and new-assay projects.
Participate in audits and inspections.
Perform biennial reviews of Standard Operating Procedures.
Participate in assay improvements, new assay configurations, and validation.
Support the Clinical Operations team and manage daily laboratory operations, including scheduling and independently troubleshooting and resolving high-complexity technical and non-technical problems.
Report concerns about test quality and/or safety to the Laboratory Director or Safety Officer.
Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly use AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements.