Director, US Laboratory Operations

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. The RoleThe 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 ensures consistent delivery of quality, turnaround time, productivity, capacity, and customer commitments while continuously improving laboratory performance and scalability. The Director leads the US laboratory testing organization and associated operational support capabilities, including laboratory quality control and automation, and partners closely with Medical Directors and functional stakeholders. The role establishes the operating system, resource and capacity plans, and performance standards required to deliver high-quality clinical trial testing while advancing technology, automation, workforce capability, and continuous improvement. Essential Functions and Responsibilities Develop and execute the laboratory operating strategy aligned with GCL 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 actively manage laboratory KPIs and operating mechanisms to identify performance gaps, accelerate issue resolution, and sustain continuous improvement. Lead laboratory operations teams and associated operational support capabilities, including Lab QC and Automation, with clear accountability, standards, and performance expectations. Partner with US Medical Directors and Scientific Affairs to ensure laboratory testing is scientifically appropriate, technically robust, harmonized where required, and aligned with protocol and customer commitments. Ensure laboratory operations comply with applicable quality systems, regulatory and accreditation requirements, safety standards, SOPs, and client/study requirements; partner with Quality on deviations, CAPA, audit readiness, inspections, and regulatory responses. Own laboratory capacity and resource planning, including staffing, scheduling, space, equipment, instrumentation, maintenance dependencies, and operational readiness to support current demand and future growth. Own workforce planning, staffing, training, qualification, performance management, succession, and leadership development for the laboratory organization. Partner with Sample Management & Site Services to define and continuously improve the testing-ready handoff, resolve cross-site flow constraints, and minimize downstream impact from sample-related issues. Partner with Client Delivery and other customer-facing teams on significant laboratory performance issues, study risks, escalations, and corrective actions while ensuring timely and accurate operational communication. Develop and manage operating budgets, forecasts, capital/resource requirements, and productivity plans; identify opportunities to improve cost efficiency while protecting quality and service. Champion automation, technology, process innovation, and operating model improvements that increase laboratory capacity, reliability, efficiency, and scalability. Recruit, develop, coach, and retain high-performing leaders and teams while fostering a culture of safety, quality, accountability, scientific rigor, innovation, and continuous improvement. Key Qualifications: Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification in life sciences, laboratory science, or a related field Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) including significant leadership experience in clinical laboratory operations, pharmaceutical/biotech laboratory services, diagnostics, or a comparable regulated environment. Experience leading large teams, operational transformation, and complex laboratory operations is strongly preferred. 5+ years of management responsibility Strong leadership skills Advanced degree preferred. CAP/CLIA accreditation, or willingness and capability to obtain applicable credentialing, is desirable where relevant to the role. Knowledge, Skills, and Abilities: Executive-level laboratory operations leadership and change management In-depth knowledge of clinical laboratory operations in pharmaceutical and biotech environments Quality systems, regulatory/accreditation compliance, and audit readiness Laboratory capacity, workforce, instrumentation, and resource planning Data-driven performance management and operational analytics Automation, technology deployment, and continuous improvement Budgeting, forecasting, capital planning, and financial acumen Cross-functional integration across science, quality, sample management, and client delivery Customer and study delivery orientation Talent development, coaching, and organizational capability building Executive communication, influencing, and stakeholder management Ability to lead effectively in a fast-paced, highly regulated environment Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel up to 25% Why Join Us?Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment