Medical Lab Development Specialist

UNC Health Care Systems Chapel Hill, NC
The purpose of the medical laboratory development specialist positions in the McLendon Clinical Laboratories is, in collaboration with the assistant administrative directors and laboratory directors, to develop laboratory developed tests (LDT's) and advanced diagnostic laboratory testing (ADLT) in highly specialized laboratories. These tests have specific requirements for development and are heavily regulated by the FDA and CMS. These tests typically are performed in laboratories utilizing molecular diagnostic testing or specialized chromatographic methodologies and analytical software applications. The medical laboratory development specialist also will validate high complexity tests that may be FDA approved but require clinical correlations with existing methodologies or clinical diagnoses.

Required Expertise:

Experience with sample preparation/extraction, liquid chromatography, gas chromatography, mass spectrometry, and protein electrophoresis. Computer skills with experience in data processing and analysis of chromatography and mass spectrometry.

Education Requirements:

Bachelor's degree in Medical Technology (Clinical Laboratory Science) or in a biological science

Professional Experience Requirements:

Three years of experience in a research laboratory with techniques relevant to the specialty area.

Licensure/Certification Requirements:

Certification by a nationally recognized board/agency