R&D Scientist

Chicago-North Suburbs

• Review current literature to identify opportunities to develop or enhance existing assays and methodologies.
• Develops research study protocols to satisfy all regulatory requirements for LDT assays.
• Documents study results and assess the acceptability of such.
• Revises and refines subsequent study protocols to maximize sensitivity and specificity of assay under development.
• Summarizes study results in an appropriate format to demonstrate validation of all required parameters for a successful LDT assay.
• Prepares additional documentation for FDA approval. Monitors progress of the submission and responds to requests for additional studies and/or documentation. 
• Maintains a clean, safe, functional work environment. Serves as a role model to others.
• Adheres to all CLIA, HIPAA, and OSHA requirements.
• All other duties as assigned.  

Requirements

Degree level/Area:  Bachelor’s degree in Chemistry, Biology, Clinical Laboratory Sciences, or Medical Technology program from an accredited institution is required. Advanced degree preferred.

Certificates/Licenses: MLS/MT (ASCP), AMT, or other national accreditation preferred.