What are the responsibilities and job description for the Molecular Diagnostics Manager position at Acutis Diagnostics?
The Molecular Diagnostics Manager will oversee all pre-analytical, analytical, and post-analytical activities within the Molecular Diagnostics department, with a focus on infectious disease testing (respiratory, gastrointestinal, and urinary tract infections) and pharmacogenomics (PGx). The manager will collaborate closely with the R&D team to develop, validate, and implement new PCR-based assays (including multiplex and OpenArray platforms), while ensuring compliance with regulatory requirements and operational efficiency. This position reports directly to the Director of Operations.
Responsibilities
Responsibilities
- Lead and manage a team of molecular technologists performing high- and moderate-complexity tests.
- Provide technical support and assist with bench testing as needed to maintain departmental operations.
- Monitor and ensure turnaround time expectations are consistently achieved.
- Partner with R&D to optimize and validate molecular diagnostic assays, including multiplex PCR and OpenArray workflows.
- Execute verification and validation protocols, transitioning assays into production in alignment with regulatory standards.
- Maintain strict QA/QC compliance for all assays performed, addressing deficiencies through corrective actions.
- Recruit, train, and evaluate molecular technologist staff; foster a culture of quality, accountability, and professional growth.
- Ensure laboratory equipment is maintained, calibrated, and compliant with safety protocols.
- Troubleshoot and resolve technical problems, ensuring appropriate documentation and reporting.
- Oversee inventory management, supply ordering, and cost-effective use of consumables to meet projected test volumes.
- Perform cost analysis for assays, consumables, and workflows; identify opportunities to reduce waste and improve efficiency.
- Assist in preparing departmental budgets, forecasts, and cost reports in collaboration with operations and finance leadership.
- Maintain readiness for CAP, CLIA and NYSDOH CLEP inspections, ensuring all documentation, training, and quality records are up to date.
- Work cross-functionally with Accessioning and Technology teams to ensure streamlined operations and timely reporting.
- Lead process improvement initiatives to increase throughput, reduce turnaround times, and enhance competitiveness.
- Participate in client-facing discussions as needed to support technical and operational inquiries.
- Support after-hours and weekend operations as required to achieve laboratory goals.
