Over 10 years experience in the Contract Research organization and Pharmaceutical/Biotech industries managing QC testing for a wide variety of products from medical devices, small and large molecule and inhaled pharmaceutical products. I have held positions of increasing responsibility at two CRO's, a clinical manufacturing plant and most recently at a contract manufacturing organization as the Quality Control Manager with responsibilities for all aspects of quality control for the manufacture of biopharmaceutical products.
Responsible for the Quality Control Department at a Phase 1/2 contract manufacturing organization
Responsible for the Quality Control program for Phase 3 clinical manufacturing for a lyophilized parenteral
Responsible for the Quality Control Microbiology lab at a Contract Research Organization
Responsible for performing sterility assurance testing on pharmaceutical and medical devices in a class 8 clean room at an ISO 9002 certified and FDA registered company
Employed by the Illinois Institute of Technology, but supervised by FDA researchers located at the National Center for Food Safety and Technology
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