Dr. Crivellone’s experience in domestic and international operations harmonization, the development and management of reference standards and monographs, and strong technical background in small molecule and biologics material characterization will provide an outstanding resource for our clients.
ROCHELLE, Va. (PRWEB) December 05, 2018
NDA Partners Chairman Carl Peck, MD, announced today that Mary Crivellone, PhD, the former Director of Global Laboratory Integration at the United States Pharmacopeial Convention (USP), has joined the firm as an Expert Consultant. Dr. Crivellone is a Laboratory Operations executive with extensive experience in domestic and international operations harmonization, compendial affairs, and the development and management of reference standards and monographs. As Director of Global Laboratory Integration at USP, she was responsible for integrating operations for three global biologics laboratories in the US, India, and China. She also served as Senior Science and Standards Liaison and as Senior Reference Standards Scientist while at USP.
Dr. Crivellone has a strong technical background in small molecule and biologics material characterization (identification, purity, potency/strength, stability), product quality, protein and peptide chemistry, and molecular biology. She is an expert in analytical and biologics testing strategies, protocol design, data analysis, results review and evaluation, and has extensive experience in project management.
Prior to her industry career, Dr. Crivellone was a faculty member and Principal Investigator in the Molecular Biology Department at the University of Medicine and Dentistry of New Jersey. Additionally, she was a faculty member at the State University of New York Upstate Medical University in the Biochemistry and Molecular Biology Department and in the Cell and Molecular Biology Program.
“Dr. Crivellone’s extensive experience in domestic and international operations harmonization, and the development and management of reference standards and monographs, in addition to her strong technical background in small molecule and biologics material characterization, will provide an outstanding resource for our clients,” said Dr. Peck. “We are very pleased to welcome her to NDA Partners.”
Dr. Crivellone earned a doctorate in biochemistry from Purdue University and a bachelor’s degree in biochemistry from Michigan State University. She completed a post-doctoral fellowship in molecular biology and genetics at Columbia University.
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer