Robert E. Zoubek

Robert has 20 years of experience in development of biologics and gene and cell therapies. His expertise comprises the regulatory requirements for analytical methods, method validation, cell bank establishment, product and process development and actual manufacture. . Robert is Principal Consultant at Granzer Regulatory Consulting & Services and supports clients worldwide on CMC from early development up to marketing authorization for Europe and USA. Until he joined Granzer, Robert worked in several positions at the Formycon/Germany, a leading developer of Biosimilars for regulated markets. As Director Scientific Affairs he led Formycon´s drug product development and analytical services. Before that, Robert was Head of Protein Characterisation & Preformulation and Manager Quality Operations. In those positions he supervised Formycon´s GMP-Quality Control and analytical labs, the core of Quality-Biosimilar development. Robert earned the PhD from the University of Erlangen-Nuremberg for his research on therapeutic peptides and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.