Director of Analytical Services and Senior Laboratory Director
Dr. Menoutis has over 35 years of experience in the pharmaceutical and related industries, working extensively in the areas of quality assurance, research & development, quality control, regulatory affairs, and manufacturing. In the course of his career, he has held various research and progressive management positions with such companies as SGS, Quest Diagnostics, F. Hoffman La Roche and Givaudan. At both Roche and Givaudan he oversaw and managed a number of projects outsourced to CROs. As an analytical chemist, Dr. Menoutis has extensive experience in analytical method development for new products, expiry dating of new formulations and existing products, preparation and submission of CMC, IND and ANDA documentation, the development of quality specifications, Drug Master Files, and stability protocols. He has experience in all phases of analytical chromatography (HPLC, GC) , analytical spectroscopy ( AAS, ICP), and analytical mass spectrometry ( GC-MS, LC-MS, ICP-MS). He has extensive experience in trace and ultra –trace analysis employing GC-MS, LC-MS and ICP-MS. Dr. Menoutis is considered an expert in the field of both organic and elemental impurities analysis in drug and medical products. His seminal work in area of impurities formation and analysis in antimicrobial APIs is cited in numerous research papers, by governmental regulatory agencies (FDA, EMA), and such industry groups as the Cosmetic Ingredient Review.
He is a member of the Executive Board of the New Jersey Pharmaceutical Quality Control Association, an organization that is a signatory to the USP Convention, and whose QA/QC and Regulatory Compliance members represent over 20 global pharmaceutical companies. He is also President of the New Jersey Institute of Chemists and a faculty member of its Cooperative Education Institute. Previously Dr. Menoutis served as a member of the Life Sciences Advisory Board of the New Jersey Technology Council and also served on the board of New Jersey City University.
Dr. Menoutis is credentialed as a Certified Professional Chemist (CPC) and also as a Certified Professional Chemical Engineer (CChE) from the National Certification Commission on Chemistry and Chemical Engineering (NCCCCE). NCCCCE credentialing of chemists and chemical engineers is the oldest such program in the United States. Individuals credentialed as a CPC and or CChE are recognized as experts in their respective field of chemistry/chemical engineering by the Federal Courts and Federal Agencies. Dr. Menoutis earned a B.A. in Chemistry and Mathematics with an advanced minor in Physics and a Ph.D. in Analytical Chemistry. He also has a certificate in toxicology.
Dr. Menoutis is also an officer in the United States Air Force Auxiliary, Civil Air Patrol, with a current grade of Captain.
Technical Director and Manager of Laboratory Operations
Angela has over 37 years of diversified experience in the pharmaceutical, personal care products, and biotechnology industries with progressive and increasing technical, managerial and regulatory responsibilities. She has an extensive regulatory chemistry background, with an accumulated breadth of experience leading and managing the scientific, operational, and technological functions of GMP and GLP regulated companies. This includes many years of experience in the successful operation and management of high sample throughput contract analytical and research laboratories. Angela Has extensive experience in analytical method development for new products, expiry dating of new formulations and existing products, preparation and submission of CMC, IND and ANDA documentation, the development of quality specifications, and development of methhod validation protocols and stability protocols. She has broad experience in all aspects of analytical chemistry inclusive of HPLC, GC, MS and numerous other analytical techniques. In the field of analytical chromatography, Angela studied under Dr. Robert Grob and Dr. Throck Watson. And, is considered an expert in the areas of analytical chromatography and mass spectrometry. Her responsibilities include management of the entire analytical chemistry group, and overseeing the company’s contract services operations. Prior to joining Quantex, she held various research and management positions within Colgate Palmolive, Lonza and the CRO Analab.
She is also a member of a number of professional and scientific societies and a member of the Board of the New Jersey Institute of Chemists. She previously served as a member of the leadership of the New York Section of the AOAC. Angela also appears in Marquis Who’s Who in America.
Angela has a B.A. in Chemistry and in Biology and has completed significant graduate course work towards a M.S. in Chemistry. She is also a graduate of the Finnigan Institute, where she studied mass spectrometry.
Manager of Quality Assurance
Sonali manages all aspects of the Quality Assuarance Unit. Her primary responsibilities include maintaining Quantex’s comprehensive quality systems to ensure the company’s laboratories are in compliance with all federal regulations, current Good Manufacturing Practices, Good Laboratory Practices, Quality Management System , and ISO 17025 requirements. She is a trained ISO auditor, and a graduate of the New Jersey Pharmaceutical Quality Control Association’s cGMP course. She has broad experience with both wet chemistry and instrumental techniques including ICP-OES, atomic absorption and HPLC. As part of her duties, Sonali works with clients in resolving quality related issues and in hosting client audits of our facilities. She also manages regulatory audits. Sonali has a B.S. in Chemistry and an M.S. in Chemistry.
Supervisor of Chromatography Group
Working directly under the Technical Director, Matt supervises the chromatography group. His prime responsibilities involve overseeing a variety of both routine and non-routine HPLC and GC testing. He directs project assignments and work flow to assure deadlines are met, and oversees validation and verification projects. Matt is also involved with carrying out method development and validation work involving HPLC and GC-MS. He has extensive chromatography experience including the use of novel detectors. He is a graduate of the New Jersey Institute of Chemists Advanced cGMP Chromatography and its cGMP Analytical Chemistry courses. Matt has a B.S. in Biology with a minor in Chemistry.
Director of Scientific and regulatory Affairs
Dr. Chaudhri has over 35 years of pharmaceutical experience encompassing analytical research and development, quality control, quality assurance and regulatory affairs. He has held various research and management positions with such companies as Lederle, Aventis and TEVA Pharmaceuticals. Dr. Chaudhri has extensive experience in analytical method development for new products, expiry dating of new formulations and existing products, preparation and submission of CMC, IND and ANDA documentation, the development of quality specifications, Drug Master Files, RM, FP and stability protocols. He is a Fellow of the American Institute of Chemists and is a member of a number of professional and scientific societies. He has a Ph.D. in Analytical Chemistry