Molecular Laboratory Supervisor

CareWell Health•East Orange, NJ

About The Position

The Molecular Laboratory Supervisor oversees the daily operations of high-complexity testing in a molecular diagnostic laboratory. The role plans, develops, implements, evaluates, and monitors laboratory operations to deliver high-quality, efficient, and timely services. It leads molecular/genomic testing start-up and development, assay development and validation, personnel training, validation documentation, and inventory management. Under managerial direction, the supervisor oversees laboratory operations and personnel performing testing and reporting results, and has authority over testing personnel. The position performs complex laboratory procedures, prepares and processes specimens, operates molecular testing equipment, and reports molecular laboratory results. It maintains equipment performance, quality standards, supplies, laboratory information systems, and compliance with applicable policies and procedures. The supervisor must be accessible to the laboratory as needed for on-site, telephone, or electronic consultation. The role also supports new programs, tests, methods, instrumentation, and procedures; coordinates staffing and work assignments; provides orientation and training; ensures corrective and remedial actions; and complies with state and professional continuing education requirements. The job description notes that duties and responsibilities may change and are not limited to the listed activities.

Requirements

Bachelor of Science degree in Medical Technology, Molecular Biology, Chemical, Physical, Biological Science, or another related field.
MT (ASCP) or MB (ASCP) certification.
Meet CLIA requirements for personnel performing molecular/genomic testing.
At least 4 years of laboratory experience, including at least 1 year in molecular diagnostic testing.
Hands-on experience with PCR techniques and DNA/RNA isolation methods.
Proven experience in clinical molecular assay design, validation, and implementation in accordance with regulatory requirements.
Extensive experience in complex diagnostic molecular testing, including hands-on Next-Generation Sequencing and PCR assays.
Ability to solve complex problems independently and as part of a team.
Strong attention to detail and organizational skills.
Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
Excellent verbal and written communication skills.
Critical thinking and efficient, effective problem-solving skills.
Ability to manage multiple projects, set priorities, and meet deadlines.
Strong interpersonal skills and a professional demeanor.

Nice To Haves

Master’s degree in Molecular Biology or a related field.
Experience with bioinformatics tools.
Previous supervisory experience in molecular biology or infectious disease testing.

Responsibilities

Supervise and oversee daily laboratory operations and personnel performing high-complexity testing and reporting test results.
Lead molecular/genomic testing start-up and development projects and support the development of high-quality testing services.
Develop and validate molecular assays, including preparing and supervising validation protocols and procedures and completing validation reports.
Lead and guide medical technologists, laboratory assistants, and other laboratory staff.
Collaborate with laboratory management to maintain staffing and productivity monitors.
Prepare and process specimens, operate molecular testing equipment and analyzers, and report laboratory results.
Calibrate, standardize, adjust, maintain, and perform routine or preventive maintenance on molecular/genomic laboratory equipment.
Develop, write, or modify policies and procedures for molecular/genomic testing.
Perform and manage the proficiency testing program for molecular/genomic testing.
Perform quality control and quality assurance procedures, including maintaining logs and files and recording data.
Review, evaluate, and document problems and corrective action reports in accordance with established policies and procedures.
Troubleshoot basic instrumentation, reagent, technical, and methodology problems, and resolve technical problems in accordance with Laboratory Director policies and procedures.
Conduct in-service training, manage and assist with bench training, and provide orientation for testing personnel.
Ensure remedial actions are taken when test systems deviate from established performance specifications.
Maintain equipment performance by establishing quality standards and procedures, ensuring staff compliance, certifying instrument performance, and arranging equipment replacement, service, and repair.
Manage laboratory supplies inventory, including checking stock, anticipating needs, ordering and expediting supplies, and verifying receipts.
Maintain the medical laboratory information system by identifying information needs and problems, recommending improvements, setting priorities, testing, writing user manuals, training employees, and maintaining security and confidentiality.
Facilitate new programs, tests, methods, instrumentation, and procedures by investigating alternatives, preparing proposals, developing and performing parallel testing, and monitoring progress.
Schedule and assign employees and follow up on work results.
Comply with state and professional continuing education requirements and follow infection control, environment of care, and safety procedures, including appropriate PPE use.
Participate in service improvement projects and perform other duties as assigned or requested.