Acutis Diagnostics
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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
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.
Senioriy level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Hospitals and Health Care
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Get AI-powered advice on this job and more exclusive features.
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
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.
Senioriy level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Hospitals and Health Care
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr