Associate Director, Lab Operations

CSL Plasma•Knoxville, TN

About The Position

The Associate Director, Laboratory Operations reports to the Director of Laboratory Operations and provides leadership for laboratory operations at the Knoxville Laboratory. The role is accountable for overall 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 the laboratory meet safety, quality, service, financial, and operational goals, while working with business partners to maintain safe, compliant, efficient operations and prepare for future growth. The role translates laboratory-wide goals into departmental plans, sets and monitors KPIs, reviews performance, and contributes to operational reporting. It leads process and infrastructure improvements, uses operational data to address root causes and improve performance, and manages capacity for high-volume testing needed to release plasma to customer specifications. The Associate Director ensures regulatory compliance and inspection readiness, including adherence to FDA, CLIA, GHA, cGMP, and internal SOPs, and drives corrective and preventive actions. The role develops operational leaders and oversees staffing, succession planning, leadership development, employee relations, and workforce planning. It supports budgets and resource allocation, partners with functions including Quality, Validation, Human Resources, Facilities, IT, and Engineering, and represents laboratory operations with internal and external stakeholders. The position also promotes a safe and compliant workplace, oversees facility standards, leads significant operational changes, and supports adoption of new technologies, equipment, systems, and process improvements. The environment is fast-paced, with frequent interruptions and accountability for a 7-day (24/6) high-volume testing operation. The role requires a flexible schedule, including possible evenings, weekends, and holidays, occasional presence on alternate shifts, and overnight travel up to 15–20% of the time.

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.
Demonstrated working knowledge of FDA regulations, including GMP, GLP, and CLIA standards.
Experience monitoring departmental budgets and managing resource allocations.
Proven ability to manage, motivate, and develop supervisory teams.
Strong written, verbal, and presentation skills to communicate metrics and drive operational results.
Excellent 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 work a flexible schedule, including weekends, evenings, and holidays.
Ability to travel overnight up to 15–20% of the time.
Ability to wear personal protective equipment and tolerate occasional exposure to extreme temperatures and bloodborne pathogens.
Ability to lift and carry up to 40 lbs.

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 to customer specifications.
Ensure adherence to FDA, CLIA, cGMP, and internal SOPs; maintain inspection readiness; drive CAPA; and ensure staff are trained on current SOPs.
Lead and develop Managers, Senior Managers, and operational leaders; oversee staffing, succession planning, leadership development, employee relations, and workforce planning.
Support operating budget development, 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 and resolve challenges.
Represent laboratory operations and build relationships with internal and external stakeholders; support business continuity, benchmarking, customer service, and operational planning.
Promote 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 (EHS), OSHA, and SOP requirements.
Lead major operational changes affecting laboratory functions, staffing, workflows, systems, or business processes.
Support implementation and adoption of new technologies, equipment, and operational improvements.
Provide operational oversight across all seven days of operation and multiple shifts, including occasional visibility on alternate shifts and management of critical escalations.