Description

Job Role Summary

The Director of the Public Health Laboratory is responsible for leading laboratory operations, ensuring quality control, compliance with regulatory standards, and the effective allocation of resources to support the operation of the public health laboratories. This role oversees laboratory staff, plans for and maintains the laboratory budget and business processes, collaborates with government agencies, and drives innovation in laboratory practices. The Director ensures that laboratory services meet the regulatory requirements and the needs of public health programs and stakeholders through effective management, strategic planning, and performance evaluation.

Essential Duties

Laboratory Management (70%)

• Oversee all laboratory operations, ensuring compliance with state and federal regulations, including quality control and safety standards.
• Develop and implement laboratory policies and procedures to improve operational efficiency.
• Manage the procurement of laboratory supplies and equipment, maintaining compliance with budgetary constraints and regulatory requirements.
• Ensure that laboratory staff receive appropriate training and maintain necessary certifications to perform their roles effectively.
• Conduct regular performance evaluations, providing coaching and development opportunities for laboratory staff.

Regulatory Compliance and Reporting (20%)

• Act as the primary liaison with regulating agencies, ensuring timely communication and compliance with public health standards.
• Prepare and submit necessary documentation and reports for regulatory agencies and funding bodies.
• Develop and implement protocols for public health investigations and special projects as required.

Research and Development (10%)

• Lead efforts to adopt new laboratory technologies and methodologies that enhance testing capabilities and improve service delivery.
• Coordinate special projects related to public health initiatives, research collaborations, and community outreach programs.
• Analyze laboratory data to identify trends and provide recommendations for public health interventions.

Requirements

Qualifications

Must meet the qualifications for one of the pathways under CMS 42 CFR 493.1405

Education Doctoral degree

Required: one of the following 2 options

Doctoral degree: Hold an earned doctoral degree in a chemical, biological, clinical, or medical laboratory science from an accredited institution.

Physician path: Hold a doctoral degree in medicine (MD), osteopathy (DO), or podiatry (DPM). Be certified in either anatomic or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

Have at least one year of experience directing or supervising high-complexity testing.

Continuing Education
Complete at least 20 CE credit hours in laboratory practice that covers director responsibilities.

Experience:

• Minimum of 8-10 years of progressive experience in clinical laboratory management, quality assurance, or public health laboratory services, with at least 3-5 years in a supervisory or leadership role.
• Proven experience in leading laboratory teams and managing operations in compliance with regulatory standards.
• Significant experience managing budgets, procurement, and vendor relationships in a laboratory setting.

Licenses/Certifications Required

• Be certified by a board approved by HHS, such as the American Board of Bioanalysis (ABB) or the American Board of Clinical Chemistry (ABCC).

Knowledge, Skills & Abilities

• Comprehensive understanding of laboratory operations, including clinical testing, microbiology, and quality control standards.
• Proficient in data analysis and interpretation, with the ability to generate reports and presentations for diverse audiences.
• Strong leadership skills, with experience in project management and team development.
• Excellent communication skills to effectively collaborate with internal teams, external stakeholders, and regulatory agencies.
• Familiarity with laboratory information management systems (LIMS) and emerging laboratory technologies.

Working Environment

The role generally involves a combination of office and laboratory settings. If needed, the laboratory director may serve as testing personnel. In that case, a heightened emphasis on safety protocols. When serving as testing personnel, tasks may require sustained periods of standing, walking, and extensive use of hands for operating laboratory equipment. Exposure to biological specimens, chemical reagents, and laboratory odors is a daily occurrence; therefore, adherence to safety guidelines and the use of personal protective equipment (PPE) is mandatory.