Dr. Matthias Fischbach

Quality oversight on the Merck Healthcare Biotechnology Manufacturing Network.

Leads the Global Launch Management Team ensuring global launch of entire Merck HC pipeline (Small Molecules, Large Molecules and Biosimilars), as well as all Lifecycle Products according to plan (net sales > EUR 2 billion). Recent successful launches: Bavencio & Mavenclad & Tepmetko & Euthyrox NF & Gonal F Pen. Leads a multi-cultural team of senior experts responsible for C(D)MO and CMO management, GMP manufactures, Business Partner of Business Franchise Leadership Team.

Leads the Global Launch Management Team ensuring global launch of Merck Healthcare pipeline (Small Molecules, Large Molecules and Biosimilars), as well as all Lifecycle Products according to plan (net sales > EUR 2 billion). Recent successful launches: Bavencio & Mavenclad. Leads a multi-culture team of senior experts responsible for CMO management, GMP manufactures, Tech Transfers from R&D to internal or external manufacturing sites. Business Partner of Business Franchise Leadership Team.

Leading the Global Pharmaceutical Quality Systems team ensuring that comprehensive, effective and efficient QMS are established, documented, maintained and continuously improved. Defining and accomplishing the Global Quality IT strategy. Global responsibility for deployment, validation and maintenance of electronic Quality Systems and digital Quality technologies. Global responsibility in defining, deploying and maintaining Quality Learning Management Systems (PQS related to GMP and GDP).

Global responsibility for Project Transfers to Contract Manufacturing Organizations (CMO) and New Product Introductions of Merck Serono NCE pipeline (parenterals and solids). Evaluation and selection of New CMO and CMO maintenance. Conduction of state of the art Technical Process Transfers. Establishment of KPIs. Preparation of submission and product launches.

Global responsibility for Formulation and Process Development activities of Merck Serono NCE pipeline; including global NCE Life Cycle Management activities. Establishment of new concepts e.g. (QbD & PAT), Continuous Manufacture, Process Scale-up & transfer to routine production and manufacturing process validation. Preparation of submission dossier (NDA/MAA).

Associate Director Formulation & Process Development International Technical Project Leader (Phase III Projects) Scale-up & Project Transfer QbD-expertise & 14 AMG

International Technical Project Leader (Phase III Project, CMC) Formulation & Process Development IVIVC QbD § 14 AMG

International Technical Project Leader, IVIVC Formulation & Process Development Scale-up expertise

Business administration & marketing

PhD-Student at Johann Wolfgang Goethe University Frankfurt, Insitute for Pharmaceutical Technology, Biocenter, PhD-Thesis: "Forecasting the in-vivo performance of modified release dosage forms using biorelevant dissolution tests" AK: J.B. Dressmann

Pharmaceutical Technology, Biochemistry, Chemistry, Pharmacology, Clinical Pharmacy and Biology