Senior Director, Medpace Bioanalytical Laboratories
Medpace, Cincinnati, OH, USA
Dr. Michael Zhou is currently Senior Director of Medpace Bioanalytical Laboratories with Medpace, Inc. (a Clinical Research Organization). His most recent positions were Senior Associate at Lachman Consultants and Senior Director of Global R&D at Bioanalytical Systems and Director of Bioanalytical Chemistry/DMPK at Synta Pharmaceuticals Corporation. He previously held positions at DuPont, Purdue Pharma LP, Johnson & Johnson, Cardinal Health, and Scynexis with increasing responsibilities for analytical, bioanalytical and DMPK R&D in support of drug/product R&D and clinical/ manufacturing programs.
His career has focused on analytical and bioanalytical R&D and CMC plus DMPK programs for over 20 years, with expertise in regulatory compliance such as GLP, GCP, GCLP, cGMP regulations (or GxPs), EMA, ICH, AMV and BMV guidelines, along with USP standards and ISO certification. During his career tenure, he has gone through a few FDA audits with great success. He has worked on resolving regulatory compliance issues (FDA Warning Letters and Consent Decrees) with great credentials. He has managed and built excellent quality systems (GxPs) with Six Sigma process excellence and Lean operation. He has gained a great deal of experiences in management (functional and operational aspects), technical and regulatory compliance expertise since 1988. He has been actively involved in organizing conferences, speaking at presentations and sharing his knowledge at workshops for numerous national and international proceedings as Keynote Speakers, Invited Speakers, workshop and short course leaders.
He serves as a member of scientific steering committees for PBA and NABF, and is a member of AAPS, ACS, ASMS and AACR. He authored over 40 research articles and 2 book chapters in the areas of analytical/bioanalytical chemistry. He is a peer-reviewer for several renowned technical journals including J. AOAC International, J. Analytical Chemistry, J. PBA, and J. Chromatogr. B, etc. He serves as an Editorial Board Member for “Bioanalysis,” edited by Future Science Group of London, UK. He was retained by John Wiley and Sons (a world renowned scientific publisher) for a book entitled “Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives” (published in Jan 2011). He received his Ph.D. from the University of Delaware under the supervision of Dr. Donald L. Sparks, Chair and DuPont Professor.
Packard MultiProbe and Tomtec System (96-well), Hamilton STAR robot, UV-VIS Spectrophotometer, FL and IR Spectrophotometers, Thin Layer Chromatographic Scanner, Capillary Electrophoresis, and Ion/Liquid or Gas Chromatographic systems with related detectors (FID, NPD, ECD, FPD and MSD for GC; UV, RI, FL, EC and PRD for LC), AA, IR, Cohesive HTLC, LC-MS/MS and GC-MS/MS systems with CI, EI, Ion-Trap, etc. for GC-MS; APCI, API-ESI, Ion-Trap, MALDI-TOF, Q-TOF, etc. for LC-MS and Tandem Mass Spec and NMR 400/500.