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-Participated in inspections of a tablet repacker as well as a transdermal patch drug manufacturer-Conducted independent inspection of an OTC topical analgesic manufacturer -Participated in mass drug seizure at local generic firm cited for failure to properly follow cGMPs-Trained in proper FDA investigation techniques and regulations relating to GMP & GLP-Studied numerous inspectional reports from recent pharmaceutical inspections in Michigan & Indiana-Conducted drug and medical device recall audits assessing the effectiveness of industry-initiated recalls

-Produced pre-clinical as well as developmental batches of polymerized bovine hemoglobin products -Bench and pilot scale work on hemoglobin polymerization as well as subsequent fractionation via diafiltration at the 0.5, 2, 15 and 65 liter scales-Extensive experience with peristaltic & centrifugal pumps, tangential flow filtration (TFF), hydrophobic and hydrophilic capsule filters, 2 to 65 liter process vessels, 2 to 500 L process tanks & lab water systems-Assisted in building diafiltration system at previously mentioned scales -Well-versed in cleaning and conditioning techniques for cassette TFF membranes-Analytical experience with HPLC, osmometry, co-oximetry and pH/conductivity measurements-Updated numerous SOPs and diagrams using Word, Excel & Visio and wrote several technical reports-Conducted qualification on new membrane to replace obsolete filter for GMP manufacturing facility-Adhered to Good Laboratory Practices (GLPs) including keeping lab notebooks

-Worked under Technical Operations in support of Humira manufacturing-Isolated monoclonal antibodies from cell culture supernatant using both Akta Prime and Akta Explorer chromatography units-Conducted affinity HPLC to determine purified antibody titer-Evaluated an automated, capillary electrophoresis unit for use in downstream processing support. Produced a technical report and oral presentation to summarize results at completion of project-Adhered to Good Laboratory Practices (GLPs) including keeping a lab notebook-Trained fellow interns on Akta chromatography machines as well as SDS-PAGE

-Projects included SDS-PAGE, real-time PCR, ELISA and handling RNA, DNA & proteins-Isolated specific cell types from human lymphocytes by magnetic labeling-Experience handling and culturing E.coli bacteria as well as cancerous mammalian lymphocytes-Progress detailed in lab notebook and at weekly lab meetings with co-workers and supervisors-Trained lab volunteers from neighboring Wayne State University