Head of Counterfeit Protection Management at Bayer AG

Stephan Schwarze, PhD

 Stephan Schwarze, PhD

Stephan Schwarze has been Head of Counterfeit Protection since 2005. He has developed and implemented processes to prevent counterfeit medicinal products and is a recognised expert in this area. He is involved in different working groups for national and international associations and holds presentations on the subject of preventing counterfeit medicinal products.

After graduating in Pharmacology and receiving a PhD in Pharmaceutical Technology, Stephan Schwarze joined Schering in 1992 where he worked in different positions with increasing responsibility in various areas of research, development, manufacturing and from 2005 in quality assurance.

His professional career began in an interdisciplinary research team in contrast agent research. After switching to manufacturing, he developed a computer and cleaning validation concept. He then worked as Deputy Head of Operations and Manufacturing and managed the QC laboratory in Solids Manufacturing. As an assistant to the executive board, he focused on strategic projects such as the construction of a new parenteral production facility. After successful national and international‑ pre-approval inspections, he took on his position as Head of Counterfeit Protection which had only just been introduced.

Since May 2022, the position has been part of the Manufacturing Science & Technology unit, where it is closely networked with the Track & Trace unit. With this adjustment, Stephan Schwarze has the overall responsibility and coordinates the counterfeit defense for all medicines of Bayer AG.

As a sought-after expert, Stephan Schwarze is strongly involved in the internal and external training. He brings his knowledge to numerous association groups (e.g. efpia, vfa, PSI, PharmaLedger Association), currently in particular to the European Alert Management System (EAMS) as efpia representative in it‘s Alert Management Advisory Group (AMAG). He is also involved in working on standards (DIN/CEN/ISO) as well as in the European Alliance for Access to Safe Medicine (EAASM), a non-profit organization.

He is author or co-author of the following chapter of GMP Compliance Adviser:

  • 21.H Fight against counterfeit medicines