Associate Director, Lab Operations

CSL•Knoxville, TN

About The Position

Reporting to the Director of Laboratory Operations, the Associate Director provides leadership for laboratory operations at the Knoxville Laboratory. The role is responsible for operational performance, quality, compliance, staffing, and resource management across laboratory functions and shifts. The Associate Director leads Managers, Senior Managers, and operational support leaders to help meet safety, quality, service, financial, and operational goals. The position works with the Director and partners in Quality, Validation, Human Resources, Facilities, IT, Engineering, and other functions to support a safe, compliant, efficient operation and prepare the laboratory for future growth. The role translates laboratory-wide goals into department plans, establishes and monitors KPIs, conducts performance reviews, analyzes operational data, and implements course corrections and process improvements. It manages day-to-day capacity and organizational capability for high-volume testing required to release plasma to customer specifications. The Associate Director supports budgets, staffing plans, and resource allocation; leads operational changes and technology or equipment improvements; and oversees leadership development, workforce planning, and succession planning. The position ensures compliance with applicable regulatory requirements and SOPs, maintains inspection readiness, and drives corrective and preventive actions. It promotes safety and oversees facility standards, collaborates with internal and external stakeholders, and supports business continuity, benchmarking, customer service, and operational planning. Work takes place in a fast-paced environment with frequent interruptions. The role involves frequent sitting and a moderate amount of walking and standing on the laboratory floor. The employee must be able to wear PPE and tolerate occasional exposure to extreme temperatures and bloodborne pathogens, and lift or carry up to 40 pounds. Overnight travel is required up to 15–20% of the time. A flexible schedule, including weekends, evenings, and holidays, is needed to provide oversight across all seven days of operation and multiple shifts. Operational accountability covers a 7-day (24/6) high-volume testing environment, with occasional visibility on alternate shifts for leadership support and critical escalations.

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology, from an accredited institution.
At least 8 years of relevant laboratory experience.
At least 4 years of leadership experience in a laboratory, healthcare, manufacturing, pharmaceutical, biologics, or other regulated environment.
Working knowledge of FDA regulations, including GMP, GLP, and CLIA standards.
Experience monitoring departmental budgets and managing resource allocations.
Ability to manage, motivate, and develop supervisory teams.
Strong written, verbal, and presentation skills to communicate metrics and drive operational results.
Strong critical reasoning and analytical skills to resolve recurring operational defects and manage shifting priorities under tight deadlines.
Ability to compute, analyze, and interpret operational data and statistical forecasts.
Ability to wear personal protective equipment and tolerate occasional exposure to extreme temperatures and bloodborne pathogens.
Ability to lift or carry up to 40 pounds.
Ability to work a flexible schedule, including weekends, evenings, and holidays, and provide oversight across multiple shifts.
Ability to travel overnight up to 15–20% of the time.

Nice To Haves

Medical Technologist.

Responsibilities

Translate laboratory-wide goals into actionable plans for assigned departments; establish KPIs and lead performance reviews.
Monitor laboratory operations KPIs, implement course corrections, and contribute to monthly operational reports and presentations.
Lead initiatives to improve laboratory efficiency, throughput, and quality, including infrastructure upgrades and system enhancements.
Analyze operational data to identify trends and root causes and implement corrective actions to improve performance.
Manage day-to-day capacity and organizational capability for high-volume testing required to release plasma according to customer specifications.
Ensure compliance with FDA, CLIA, GHA, cGMP, and internal SOP requirements; maintain inspection readiness and drive corrective and preventive actions.
Ensure staff are trained on current SOPs.
Lead and develop Managers, Senior Managers, and operational leaders.
Oversee staffing plans, succession planning, leadership development, employee relations, and workforce planning.
Support development of operating budgets, staffing plans, and resource requirements; monitor financial performance and align resources with operational demands and business priorities.
Partner with Quality, Validation, Human Resources, Facilities, IT, Engineering, and other business partners to support operations, implement improvements, and address challenges.
Represent laboratory operations and build relationships with internal and external stakeholders; support business continuity, benchmarking, customer service, and operational planning.
Promote a culture of safety and compliance; ensure facility maintenance meets operational and regulatory standards and maintain a clean, efficient, and safe work environment.
Ensure adherence to Environmental Health and Safety requirements, OSHA, and SOPs.
Lead major operational changes affecting laboratory functions, staffing, workflows, systems, or business processes.
Support implementation of new technologies, equipment, and operational improvements while ensuring organizational readiness and adoption.
Provide operational oversight across multiple shifts and the seven-day operating schedule; occasionally be present on alternate shifts to support leaders and manage critical escalations.