Location:

AON Lab

Pay Range:

$77,833.60 - $152,796.80

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.

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