Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the TU München, Germany. He has more than 15 years industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 10 years he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early and late-stage development; he then took on the responsibility as the Lead for EU CMC Regulatory Policy for Roche Pharma Global Technical Operations in 2011. Markus is based in Basel, Switzerland. He is currently the chair of EBE’s Biomanufacturing working group and the EFPIA deputy topic lead for ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management).