Aptuit Consulting is pleased to announce the appointment of Marc Andersen Ph.D., to the position of Associate, CMC practice. He will be a member of the Lexington MA office of the company but physically located in Raleigh-Durham, NC.
Dr. Andersen brings 15 years of diverse experience in the discovery and development of small molecule active pharmaceutical ingredients from large pharma and the CRO industries.
Prior to joining Aptuit, Dr. Andersen was Director of Pharmaceutical Sciences at Beckloff Associates where he provided regulatory consulting on API development and gained experience in the preparation of CMC modules for drug substance and drug product NDAs and ANDAs. Prior to this, Dr. Andersen held the position of Project Director at Cardinal Health where he managed contract synthesis and analytical service outsourcing. At Cardinal Health, Dr. Andersen was project leader for development, testing, and pre-formulation studies to prepare cGMP toxicology and clinical API supplies for over 40 different NCEs. During this period he also managed an API development program culminating in a DMF and ANDA filing. Earlier in his career, Dr. Andersen worked at Glaxo Wellcome in the Medicinal and Chemical Development Divisions. Dr. Andersen earned his Ph.D. at Philipps University in Marburg, Germany and went on to complete a postdoctoral appointment at the University of South Carolina.
“Dr Andersen brings strong experience in small molecule scale-up and process chemistry to Aptuit Consulting” commented Dr. William Kerns, Managing Director. “In addition, his capability of providing CMC regulatory advice will be of particular value to our clients.”