Director, US Laboratory Operations

Thermo Fisher Scientific•Highland Heights, KY

About The Position

The Director, US Laboratory Operations provides dedicated operational leadership for the Highland Heights laboratory operation and is accountable for the safe, compliant, reliable, and efficient execution of US laboratory testing. The role leads the US laboratory testing organization and operational support capabilities, including laboratory quality control and automation, and partners with Medical Directors and functional stakeholders. It establishes the operating system, resource and capacity plans, and performance standards needed to deliver high-quality clinical trial testing while advancing technology, automation, workforce capability, and continuous improvement. The position owns end-to-end laboratory operational performance, including safety, quality, turnaround time, productivity, capacity, schedule attainment, cost, and service delivery. It develops and executes operating strategy, manages performance through KPIs, ensures compliance with quality and regulatory requirements, and oversees workforce, capacity, budget, and resource planning. The Director also supports customer and study delivery, cross-functional handoffs, operational transformation, and the development of high-performing teams.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification in life sciences, laboratory science, or a related field.
Comparable to 12+ years of relevant experience, including significant leadership experience in clinical laboratory operations, pharmaceutical or biotech laboratory services, diagnostics, or a comparable regulated environment.
At least 5 years of management responsibility.
Executive-level laboratory operations leadership and change management skills.
In-depth knowledge of clinical laboratory operations in pharmaceutical and biotech environments.
Knowledge of quality systems, regulatory and accreditation compliance, and audit readiness.
Skills in laboratory capacity, workforce, instrumentation, and resource planning.
Data-driven performance management and operational analytics skills.
Knowledge of automation, technology deployment, and continuous improvement.
Budgeting, forecasting, capital planning, and financial acumen.
Ability to integrate cross-functionally across science, quality, sample management, and client delivery.
Customer and study delivery orientation.
Talent development, coaching, and organizational capability-building skills.
Executive communication, influencing, and stakeholder management skills.
Ability to lead effectively in a fast-paced, highly regulated environment.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

Experience leading large teams, operational transformation, and complex laboratory operations.
Advanced degree.
CAP/CLIA accreditation, or willingness and capability to obtain applicable credentialing where relevant.

Responsibilities

Develop and execute laboratory operating strategy aligned with business priorities, customer commitments, scientific requirements, quality standards, and growth plans.
Own end-to-end operational performance for US laboratory testing, including safety, quality, turnaround time, productivity, capacity, schedule attainment, cost, and service delivery.
Establish and manage laboratory KPIs and operating mechanisms to identify performance gaps, resolve issues, and sustain continuous improvement.
Lead laboratory operations teams and operational support capabilities, including Lab QC and Automation, with clear accountability and performance expectations.
Partner with US Medical Directors and Scientific Affairs to ensure testing is scientifically appropriate, technically robust, harmonized where required, and aligned with protocols and customer commitments.
Ensure compliance with quality systems, regulatory and accreditation requirements, safety standards, SOPs, and client and study requirements; partner with Quality on deviations, CAPA, audits, inspections, and regulatory responses.
Own laboratory capacity and resource planning, including staffing, scheduling, space, equipment, instrumentation, maintenance dependencies, and operational readiness.
Own workforce planning, staffing, training, qualification, performance management, succession, and leadership development.
Partner with Sample Management & Site Services to improve testing-ready handoffs, resolve cross-site flow constraints, and minimize downstream impacts from sample-related issues.
Partner with Client Delivery and other customer-facing teams on laboratory performance issues, study risks, escalations, and corrective actions, ensuring timely and accurate operational communication.
Develop and manage operating budgets, forecasts, capital and resource requirements, and productivity plans; identify cost-efficiency opportunities while protecting quality and service.
Champion automation, technology, process innovation, and operating model improvements to increase laboratory capacity, reliability, efficiency, and scalability.
Recruit, develop, coach, and retain high-performing leaders and teams while fostering safety, quality, accountability, scientific rigor, innovation, and continuous improvement.