Position Summary

The Manager, Molecular Diagnostics is responsible for building, implementing, and overseeing the Next Generation Sequencing (NGS) testing program at the Company’s central laboratory. This role provides technical leadership across NGS and PCR testing operations, including assay development, validation, workflow optimization, informatics integration, and regulatory compliance. The Manager ensures high-quality, efficient laboratory operations while coordinating daily specimen processing and supervising technical staff within the Molecular Diagnostics department. The position works closely with Pathologists, physicians, laboratory leadership, vendors, and IT resources to ensure accurate test performance, compliance with CAP and CLIA requirements, and continuous improvement of laboratory services. CLIA delegated as Technical Supervisor of Molecular Pathology.

Key Performance Areas

KPA 1: NGS Program Development & Implementation

Lead the planning, development, and go-live of NGS testing at the Company’s central laboratory.
Develop and implement new NGS and PCR assays based on clinical and operational needs.
Select appropriate instrumentation and evaluate emerging technologies for feasibility and effectiveness.
Stay current with advancements in molecular diagnostics, NGS protocols, and regulatory guidance.

KPA 2: Technical Operations & Workflow Management

Oversee daily specimen processing for NGS and PCR testing, including specimen flow, prioritization, and turnaround time.
Establish, monitor, and adjust laboratory workflows to optimize efficiency, accuracy, and capacity utilization.
Perform and oversee specimen processing, testing, analysis, and interpretation of NGS and PCR results as needed.
Perform instrument maintenance, quality control, and troubleshooting to ensure continuous operational readiness.

KPA 3: Validation, Quality Assurance & Regulatory Compliance

Direct and oversee validation of NGS and PCR instruments, methodologies, and systems prior to clinical implementation.
Ensure adherence to laboratory Standard Operating Procedures (SOPs) and standard work practices.
Monitor daily technical systems for quality and efficiency and implement corrective actions when required.
Maintain laboratory compliance with CAP, CLIA, and all applicable federal and state regulations.
Prepare for and support CAP inspections and regulatory audits.

KPA 4: Informatics & Data Management

Collaborate with vendors and IT resources to implement and maintain NGS informatics solutions.
Ensure data integrity, accurate result reporting, and appropriate system functionality across testing platforms.

KPA 5: Staff Supervision, Training & Scheduling

Supervise and coordinate daily activities of Molecular Diagnostics staff to ensure effective coverage and resource utilization.
Develop staff schedules aligned with testing volume and operational priorities.
Train staff on laboratory procedures, workflows, and quality standards.
Monitor staff adherence to SOPs and provide feedback, coaching, and corrective guidance as needed.
Delegate responsibilities appropriately to maximize efficiency and staff development.
Authorized to initiate actions and make decisions within established policies and procedures, with regular managerial oversight.
Responsible for departmental planning, performance metrics, and continuous improvement initiatives.

KPA 6: Inventory, Equipment & Resource Management

Coordinate ordering and inventory management of supplies, reagents, and chemicals.
Monitor volume trends and ensure adequate stock levels to support testing demand.
Ensure all laboratory equipment is maintained in safe, compliant, and working order.
Maintain clean, organized work areas and accurate laboratory records.

KPA 7: Leadership, Communication & Collaboration

Communicate effectively with laboratory staff, physicians, Pathologists, and other stakeholders regarding testing processes and specimen issues.
Collaborate with laboratory leadership and other department supervisors to improve efficiency, quality, and service delivery.
Interact with outside vendors and evaluate proposals for laboratory improvements.
Maintain a positive, cooperative working environment that supports employee morale and productivity.
Keep management informed of issues, trends, and risks; perform root cause analyses and recommend corrective actions as needed.

KPA 8: Research, Continuous Improvement & Professional Development

Participate in laboratory research and development projects as time and priorities permit.
Maintain required continuing education and ensure professional licensure remains current.
Demonstrate ongoing engagement in laboratory operations and quality improvement initiatives.

KPA 9: Compliance, Confidentiality & Company Standards

Ensure confidentiality of all patient and employee information at all times.
Comply with all Company, departmental, IT, safety, billing, human resources, and Disaster Recovery policies.
Adhere to all federal and state laws related to clinical laboratory operations and patient care.
Work at any Company location as needed to support business and operational requirements.
Complete additional duties as assigned.

Position Qualifications

Education

Doctoral degree in Biology, Chemistry, Molecular or related field

Minimum Relevant Experience

Minimum 3 year of related experience in a clinical setting is required.

Certifications/Licenses

MB(ASCP) certification required.
State of Florida Clinical Laboratory Supervisors license in the area pertinent to the testing being performed.
Valid state Driver’s License for travel to satellite offices and offsite meetings.

Travel: 0-25%

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American Oncology Network, Inc.

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