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Director of Quality Assurance and Regulatory Affairs
The University of Minnesota Molecular and Cellular Therapeutics (MCT) is a GMP manufacturing facility within the University division of Office of Academic Clinical Affairs. The manufacture of Cellular Translational Somatic Cell, and Standard of Care Cellular comprises about 90% of the clinical products manufacturing activity within the facility. Additional activity includes, but may not be limited to clinical related production of pancreatic islets, fecal microbiota and active pharmaceutical and drug products.The Director of Quality Assurance/Regulatory Affairs is responsible for the oversight of the quality aspects and assurance that the clinical productions meet the Food and Drug Administration (FDA) and University of Minnesota regulatory requirements. The oversight includes
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