Manager, Clinical Operations

Guardant Health

. Monitor patient, quality control, and molecular testing results .

Posted 10/16/2026full-timeRedwood City • California • United StatesSeniorLead💰 $151,200 - $207,925 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in molecular testing, quality control, and laboratory management, ensuring compliance with CLIA and CAP standards while leading teams in high-complexity environments. Proficient in project management, technical troubleshooting, and regulatory adherence to optimize laboratory operations and improve assay performance.

Highest-signal resume keywords

Molecular Biology TechniquesQuality Control ManagementRegulatory Compliance (CLIA, CAP)Laboratory Operations ManagementProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Molecular TestingQuality AssuranceAssay ValidationProcedure WritingTechnical TroubleshootingInventory ManagementData AnalysisProcess ImprovementStability StudiesLaboratory Regulations

Soft Skills

Team CollaborationProblem SolvingSupervisory SkillsTraining and DevelopmentCommunication

Tools & Technologies

Laboratory AutomationComputer SkillsInspection PreparationCorrective Action DocumentationQuality Control Software

Certifications & Qualifications

Bachelor’s Degree in Biomedical Laboratory ScienceClinical Science Certification

Industry Keywords

FDA QSRISO 13485Clinical Laboratory ExperienceHigh Complexity TestingLaboratory Audits

About the role

Key responsibilities & impact

Monitor patient, quality control, and molecular testing results
Conduct and oversee daily quantitation and qualification assessment of molecular data
Lead reagent qualification, inventory management, procedure writing, inspection preparation, assay validation, and investigations
Collaborate on quality control, quality assurance, technical troubleshooting, reagent manufacturing, and training programs
Review preventive maintenance and troubleshoot complex problems affecting test performance
Identify root causes and document corrective actions
Oversee training and competency of laboratory personnel
Manage stability studies, validation protocols, process improvement, and new assay projects
Participate in audits and inspections
Perform biennial reviews of Standard Operating Procedures
Support assay improvements, new assay configurations, and validation
Manage daily laboratory operations, including scheduling and resolving technical and non-technical high-complexity problems
Report test quality and safety concerns to the Laboratory Director or Safety Officer
Ensure adherence to CLIA and CAP standards and applicable laboratory requirements

Requirements

What you’ll need

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 computer and automation skills
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 provide direct supervision to laboratory personnel
Strong project management abilities
Ability to work as part of a team
Background screening including criminal history required

Benefits

Comp & perks

Hybrid work model with work-from-home days for eligible onsite employees
Flexible work-life balance
Reasonable accommodations for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs