What are the responsibilities and job description for the CLIA Lab Manager position at 3XGenetics?
Reports to the CEO, with clinical oversight by the CLIA Laboratory Director and Technical Supervisor.
About the role
3X Genetics develops targeted DNA enrichment and genetic testing technologies, with a focus on repeat expansion disorders such as myotonic dystrophy. We are seeking a hands-on CLIA Lab Manager to lead laboratory operations, advance clinical testing readiness, and generate rigorous assay validation data that support our testing services and technology licensing.
You will work closely with the CEO, Chief Scientist, Laboratory Director, and laboratory team to turn new methods into reliable, documented workflows. This role combines bench work, team supervision, quality management, and disciplined use of resources in a small biotechnology company.
Key responsibilities
Lead inspection readiness and coordinate CLIA and Massachusetts laboratory licensing activities with the Laboratory Director. Maintain documentation and readiness for the authorized scope of testing.
Manage specimen accessioning, DNA extraction, enrichment, library preparation, sequencing, sample tracking, and workflow troubleshooting. Protect specimen integrity and patient confidentiality.
Maintain the quality system, including controlled SOPs, quality control, proficiency testing or alternative performance assessment as applicable, internal audits, and corrective and preventive actions.
Supervise and train laboratory staff. Maintain qualification, training, and competency records; conduct competency assessments within documented qualifications and delegated authority.
Coordinate assay validation with the Chief Scientist and Laboratory Director, documenting accuracy, precision, sensitivity, specificity, reportable range, limitations, and acceptance criteria appropriate to each assay.
Review run quality and laboratory records within assigned authority. Escalate failures promptly and prevent release of affected patient results until corrective action and required review are complete.
Manage equipment qualification, maintenance, reagent inventory, purchasing, vendors, and laboratory safety. Track turnaround time, repeat rates, throughput, and cost per sample.
Prepare reproducible datasets, validation reports, and method transfer packages for research collaborators and licensing partners. Maintain clear records for clinical testing and research activities.