I am a pharmacist by training and completed my academic education by earning a Ph.D. in Pharmaceutical Technology. During 10 year in basic research I gained extensive experience in formulation development and drug targeting.
As a knowledgeable CMC specialist being responsible for pharmaceutical development of small molecules and its drug product for many years, I have extensive amount of work experience in drug development as well as project management working in an interdisciplinary drug development team. In addition logistics and drug supply for international clinical trials were also part of my responsibilities interfacing with clinical development, study centres and external service providers.
A profound knowledge of regulatory requirements completes my experience in drug development. Apart from managing production and quality control of API and IMP I have a successful track record authoring IMPDs and INDs for international clinical trial applications and preparing Module 3 for MAA/NRA dossiers. I gained sound knowledge in pharmaceutical quality assurance compliance by set up and managing quality management systems and conducting audits of 3rd parties and pre-site inspection.
At the beginning of 2011, I decided to start my own business and became an independent consultant offering consulting service in pharmaceutical drug development on issues regarding GMP, quality assurance and regulatory compliance as well as interims management for executive positions in BigPharma industry. To expand my expertise I completed an education as certified systemic business coach in 2014.