Posted 2 months ago

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.  


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.

R&D Scientist

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