anaging Scientist AAV Downstream Process Development Job - (Philadelphia, PA)

Shall oversee laboratory and several subordinate downstream process development scientists providing validation and cGMP operational support for preclinical and clinical adeno-associated virus based gene therapy products. Activities: *** Plan and lead downstream process development, qualification, and technology transfer to inhouse cGMP and outsourced Contract Manufacturing Organizations. *** Serve as technical expert on downstream process development, including harvest and clarification; purification for target AAVs, removal of impurities and contaminating viruses, virus like particles, etc. *** Supervise downstream scientists. *** Manage downstream lab facilities, operations and up coming build outs. *** Administer provision of intellectual property, protocols and SOP's to CMOs. *** Coordinate manufacturing activity at CMOs, reviewing batch records and directing GMP investigations including deviation root cause analyses, CAPA, and out-of-specification issues.