Laboratory Director

The Laboratory Director (Lab Director) is responsible for the overall operation and administration of the company's central anatomical pathology laboratory. Serving also as a technical consultant (for high complexity and moderate complexity testing), the Lab Director builds and ensures compliance with CLIA and CAP standards while also leading the process to achieve CLEP accreditations. The Lab Director is responsible for the employment of competent, qualified personnel capable of performing complex immunohistochemistry processes to support CND's test protocols. While the Lab Director delegates many core operational responsibilities, the individual is ultimately responsible and must ensure that all laboratory duties are correctly performed and applicable regulations are met at all times. The scope of the Laboratory Operations includes Laboratory Operations, Quality Control, Pathology Operations, Digital Pathology, and Pathology Pre-view.. The Lab Director collaborates closely with other key functions, including Pathology, Medical Affairs, Regulatory Affairs, Quality, Clinical Services, R&D, and Supply Chain.

Job Responsibilities:

Laboratory Operations

• Directs the planning and administration of all financial/clinical operations for the laboratory.
• Manages overall lab operations with attention to consistent implementation of policies, procedures, and business practices for all employees.
• Manages lab operations personnel activities, including recruiting, new hire onboarding, compensation determinations, training, and performance evaluations.
• Develops and updates laboratory policies and procedures and establishes evaluative and operational criteria for the facility.
• Maintains and improves all written procedures and ensures adherence to laboratory standards while overseeing proper facility and equipment maintenance.
• Directs and evaluates the adequate method verification to determine the testing accuracy and precision.
• Establishes and drives Key Performance Indicators (KPIs) that align with organizational growth and performance targets.
• Establishes effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on lab deliverables.
• Provides support and guidance to the Project Management Organization, QC and QA to ensure projects are completed on schedule.
• Monitors the progress of Projects impacting Laboratory Operations scoped to improve Operations KPIs.
• Ensures that the highest standards of quality and customer service are maintained. Collaborates with Quality staff on development and implementation of effective programs compliant with CLIA and CAP.
• Participates in the development and implementation of the department's operating budget. Establishes standards for cost control and waste reduction. Monitors utilization patterns of services and advises on explosive growth capacity improvement models.
• Maintains a strong leadership presence throughout the organization by driving scientific quality and process improvement initiatives, in collaboration with management, leads the development of strategies and priorities in the Laboratory Operations group.
• Oversees the procurement process across the laboratory operation while ensuring supply chain continuity.
• Collaborates with R&D, Quality, and Supply chain to reduce supply chain risks and deliver cost improvement initiatives through identification and qualification of alternative sources.

Regulatory and Compliance, Quality Management System

• Supports the Quality and Regulatory Affairs team during laboratory audits by internal board members and outside regulatory agencies.
• Maintains Operations inspection-ready status for state and national regulatory agencies.
• Maintains and enforces assigned area compliance programs, including related policies, procedures, and processes daily, in conjunction with organization-wide compliance efforts and federal, state, and local regulations, such as Medicare, Medicaid, and HIPPA.
• Reports on matters of business ethics, legal compliance, and operations of the laboratory.
• Supports, through leadership and oversight, the laboratory compliance management staff throughout their facilities or areas, including providing ongoing support in the development of compliance goals and objectives.
• Keeps abreast of new technical developments, implements new capabilities, systems, programs and/or procedures in the department as needed in support of improved quality and compliance levels.

Knowledge, Skills & Experience:

• 8+ years experience in a laboratory management role for a small to mid-sized CLIA and CAP certified laboratory; CLEP-certified preferred
• 8+ years in the field of histotechnology specialized in immunohistochemistry.
• Lean Six Sigma Black Belt Certification preferred
• Quality program design and implementation
• Significant experience with hiring, training, and managing laboratory technicians staff (staff of over 40 preferred)
• Strong knowledge of imaging, quality control, and credentialing, and accreditation.
• Strong knowledge of assay development/validations (IHC, ISH, EBER-ISH)
• Experience with equipment qualifications and laboratory design
• Deep knowledge in anatomic pathology for reference and private laboratories.

Education, Certifications & Licensures:

• Bachelor of Science degree in clinical laboratory science, medical technology or chemical, physical or biological science required and at least 5-10 years training and experience in high-complexity testing. Combination of education and experience considered.
• Master's degree in clinical laboratory science, medical technology or chemical, physical or biological science preferred.

Special Training:

• Validation and assay development

Other:

• Combination of seated and standing work to complete the core functions of the role.
• Ability to work onsite at the Company's Scottsdale, AZ headquarters approximately five (5) days a week.