Hybrid Clinical Operations Manager - Lab Quality Molecular

Guardant Health, Inc.; Palo Alto (CA); Hybrid; USD 151,000 - 208,000; Full time

Job summary

Guardant Health, Inc. seeks a Manager of Clinical Operations to oversee the technical operations of the Clinical Laboratory and ensure compliance with CLIA and CAP standards.

The role supervises licensed and unlicensed staff, drives quality control, SOP development, and seeks continuous improvement across testing workflows and data management while partnering with the Laboratory Director and Clinical Operations leadership.

Qualifications

• Bachelor’s degree in Biomedical Laboratory Science, Clinical Science or related field
• 8+ years clinical laboratory experience or equivalent high complexity/volume lab experience
• 2+ years of supervisory experience
• Knowledge of local, state and federal lab regulations
• FDA QSR and ISO 13485 knowledge a plus
• Experience in molecular biology techniques preferred
• Ability to lead, supervise and train lab personnel
• Strong problem-solving and communication skills

Responsibilities

• Monitor molecular testing and data quality
• Oversee reagent qualification, inventory, SOPs and inspection prep
• Lead QC/QA procedures and troubleshooting with supervisors
• Coordinate training and competency for staff
• Manage stability studies, validation protocols, and new assays
• Support audits and inspections and report test quality/safety concerns

Skills

Leadership

Quality control

Molecular biology

Regulatory knowledge

Laboratory supervision

Education

Bachelor’s degree in Biomedical Laboratory Science

Tools

LIMS

Automation software

Microsoft Excel

Job description

Guardant Health, Inc. seeks a Manager of Clinical Operations to oversee the technical operations of the Clinical Laboratory and ensure compliance with CLIA and CAP standards.

The role supervises licensed and unlicensed staff, drives quality control, SOP development, and seeks continuous improvement across testing workflows and data management while partnering with the Laboratory Director and Clinical Operations leadership.