Clinical Laboratory Director
Circular Genomics (CG) is a venture-backed biotechnology startup focused on the development of RNA-based medical diagnostics with a focus in the neurosciences. This new diagnostic technology will promote precision medicine for individuals suffering from depression and other psychiatric or neurological disorders.
Our expanding company is hiring a part-time Clinical Laboratory Director to join our management team. In this position, you will be responsible for the scope, standards, and quality of service of the Circular Genomics Clinical Laboratory. You will participate in managerial decisions and guide the operation of the laboratory ranging from preparing validation documentation for appropriate regulatory bodies, selection of staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, and utilization management.
Clinical Laboratory Director Responsibilities
Provide inspired leadership for the organization and laboratory
Participate in strategic planning for laboratory services and future testing pipelines
Direct all laboratory operations including compliance with laboratory best practices and CLIA requirements for a moderate-high complexity laboratory.
Ensure diagnostic testing adheres to federal, state and local requirements and obtain licensures when applicable.
Ensure adherence to ISO, CLIA and CAP regulatory requirements and good laboratory practices
Coordinate company testing, assay validation, and R&D support functions
Review and approve technical performance validation and verification reports for new tests, instruments, and methods prior use for sample testing
Responsible for the clinical and analytical validation of diagnostic tests
Prepare for, participate in, and perform inspections, as necessary, to maintain licensure and ensure quality service delivery.
Regularly attend meetings to discuss the management and operations of the laboratory and provide insights for continuous improvements
Ensure accurate and effective communication of laboratory data
Doctoral Degree in chemical, physical, biological or clinical lab science with current board certification from American Board of Clinical Chemistry, American Board of Medical Genetics and Genomics, or other equivalent certification
ORMD/DO/DPM and board certification in anatomic or clinical pathology
10+ years of relevant clinical laboratory experience and 5+ years of management, operations, and leadership experience
Satisfy federal and state requirements as a director of high complexity testing laboratories
Position is based in our Albuquerque, NM Facility
Circular Genomics Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.