Claudia Müller Swissmedic, Swiss Agency for Therapeutic Products

Claudia Mueller, PhD, is currently working as a Biologics Quality Assessor in the Sector of Medicinal Product Authorisation and Vigilance of Swissmedic, the Swiss Agency for Therapeutic Products in Berne, Switzerland. Before joining Swissmedic in February 2024, Dr. Mueller was working as Associate Director and Head of a Formulation Development Team within Lonza Parenteral Drug Product Services at Basel. Between 2012 and 2020, she was a Principal Scientist, Pharmaceutical Development at F. Hoffmann-La Roche Ltd.; and from 2010 to 2012 a Senior Scientist at Novartis Pharma AG. Her expertise covers, amongst others, large and small molecule parenteral drug product development including formulation and manufacturing process development for early- to late-phase and commercial products, process characterization and validation (PC/PV), quality-by-design, technology transfer to commercial production, support for clinical and commercial drug product manufacturing, and regulatory submissions (initial authorizations & post-marketing submissions). She is an author and co-author of several relevant publications and book chapters in the field. Dr. Mueller graduated as a pharmacist at The University of Jena, Germany, holds a Postgraduate Certificate in Pharmacy from the University of Otago, New Zealand and a Ph.D. in Pharmaceutical Technology from the University of Geneva, Switzerland.