A proven analytical and quality control leader offers extensive expertise in leading late-stage drug development and NDA filings. Demonstrates a keen ability to lead analytical development and quality control activities as well as CRO/CMO management. Expertise in regulatory compliance and CMC regulatory, including cGMP, ICH, USP, FDA, and EMA guidance. Excels in advanced analytical technologies including HPLC, GC, Mass Spec, FTIR, XRPD, and NMR. Strong problem solving skills.