Senior Director, Laboratory Business Operations

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

We are looking for a highly motivated individual to join Guardant’s Operations team as Senior Director of Laboratory Business Operations.  This exciting and challenging role is responsible for overseeing and optimizing reagent manufacturing, global logistics, and warehousing of reagents and consumables through direct management of a staff of over 40 employees.  Reporting to the executive leadership team, this role involves strategic planning, process improvement, resource management, and cross-functional collaboration to drive efficiency, scale, and excellence in operations. This critical role is a key senior member of the laboratory operations leadership team.

Essential Duties and Responsibilities: 

GMP Reagent Manufacturing

• Oversight and direct management of the continuous manufacturing of approximately 200 unique reagents used in the processing of hundreds of thousands patient samples scaling to millions per year.   
• Identify and opportunities for operational scaling, improvements, and streamlining processes across departments to enhance efficiency, reduce costs, and maintain high-quality standards.  
• Collaborate with internal Technology Development teams to develop and validate new automation capabilities to improve performance and increase scale.

Warehouse Management and Inventory Control

• Oversee the storage, distribution, and management of laboratory reagents and consumables related to the Clinical operation ensuring supplies are readily available for the lab when needed.
• Monitor inventory levels and collaborate with the Procurement team on forecasts to ensure sufficient stock while minimizing excess inventory and associated costs. 
• Implement inventory control measures to prevent stockouts and overstock situations.
• Supervise the organization and layout of the warehouse to maximize space utilization and ease of access, yet maintained in compliance with FDA, ISO, and CAP/CLIA regulations and safety standards.

Global Logistics Management

• Plan, implement, and manage logistics strategies, processes, and operations to ensure smooth flow of samples from global sites to Guardant laboratories and the distribution of reagents to all Guardant and partner sites globally.
• Own all aspects of patient sample inbound logistics monitoring and responding to any adverse events to minimize any disruption to the flow of clinical samples.
• Build and test Disaster Recovery capabilities to ensure a rapid and appropriate response during business continuity situations within and outside of Guardant’s control.
• Manage relationships with vendors, suppliers, and external partners to ensure smooth collaboration and delivery of services/products.
• Develop and manage the planning, coordinating, and oversight of the movement of reagents throughout Guardant sites and partner labs around the world ensuring zero stockouts at satellite sites.

General Leadership

• Develop and implement strategic initiatives that align with the organization’s goals, vision, and values.  Provide strategic guidance to ensure efficient and effective execution of operational plans.
• Ensure the organization’s operations comply with ISO, CAP/CLIA, IVDR, and FDA regulations.
• Oversee allocation of resources, including budget, personnel, and technology, to maximize operational performance and achieve business objectives.
• Foster collaboration and communication between different departments to ensure seamless integration of operations promote information sharing and drive collective achievement of company goals.
• Develop and track key performance indicators (KPIs) to monitor the health of the business.  Analyze data to make informed decisions and identify areas for improvement.
• Identify potential operational risks and develop strategies to mitigate them.  Implement contingency plans to ensure business continuity in the face of unforeseen challenges.  
• Lead and facilitate organizational