Medical Lab Development Specialist

Job Description

Description

The UNC Hospitals Molecular Genetics Laboratory is currently accepting applicants for a Medical Laboratory Development Specialist. 

Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. 

Summary: The Medical Laboratory Development Specialist works, in collaboration with the laboratory manager and directors, to develop and validate laboratory developed tests (LDTs) and advanced diagnostic laboratory testing (ADLT) in the UNC Hospitals Molecular Genetics Laboratory. These tests have specific requirements for validation and are regulated by CMS under CLIA. These tests typically are performed utilizing molecular diagnostic testing and analytical software applications. The medical laboratory development specialist also will validate high complexity tests that may be FDA approved but require clinical correlation with existing methodologies or clinical diagnoses. 

Hours: Monday through Friday 8:30am – 5:00pm Master’s degree or PhD in a chemical or biological science field is preferred. 

Responsibilities: 

1. Works collaboratively in teams as well as independently to complete the daily workload in an efficient manner. Demonstrate professional and courteous communication with employees, patients and visitors at all times. 

2. Test Development- Works closely with the faculty in the specific laboratory discipline to design test development and validation protocols. Researches literature and contacts appropriate resources to obtain information needed for development. Coordinates schedule to accommodate validation and clinical testing while meeting deadlines for development. Works with manufacturer to coordinate instrumentation modifications for testing. Coordinates tasks with other laboratory staff who may be involved in acquiring specimens, performing parallel testing, or assisting with development. Prepares protocols for new tests consistent with regulatory requirements. Prepares summaries for test validations. Troubleshoots problems occurring with development and makes recommendations on modifications to development protocols. Coordinates transition of development testing to clinical testing with laboratory directors and supervisors. Meets with clinicians, researchers, School of Medicine faculty formally and informally to discuss validation progress or to conduct educational sessions on methods. Develops new tests in compliance with regulatory guidelines. 

3. The medical laboratory development specialist may perform moderate and high complexity testing independently if they meet CLIA requirements for testing. The medical laboratory development specialist can serve as a CLIA defined general supervisor in a high complexity laboratory upon graduation from a bachelor program or as a CLIA defined technical supervisor after obtaining four years of experience in the testing area. The medical laboratory specialist may serve as a CAP defined technical consultant in performing moderate complexity competency if the medical laboratory development specialist’s education and experience meet CAP consultant criteria. 

Other Information

Other information:
Education Requirements:
● Bachelor’s degree in Medical Technology (Clinical Laboratory Science) or in a biological science.  Master’s degree or PhD in a chemical or biological science field is preferred. 
Licensure/Certification Requirements:
● No licensure or certification required.
Professional Experience Requirements:
● Three years of experience in a research laboratory with techniques relevant to the specialty area.
Knowledge/Skills/and Abilities Requirements:
● Nucleic acid (DNA and RNA) preparation and analysis, real-time PCR, sequencing. Computer skills with experience in data processing and analysis

Job Details

Legal Employer: STATE

Entity: UNC Medical Center

Organization Unit: UNCH Molecular And Cytogenetcs 

Work Type: Full Time

Standard Hours Per Week: 40.00

Work Schedule: Day Job

Location of Job: US:NC:Chapel Hill

Exempt From Overtime: Exempt: Yes