Ralf Schumacher

Currently, I’m the Head of Bioprocess and Pharmaceutical Development in the Biologicals Development Unit within Boehringer Ingelheim. In this capacity, I'm responsible for leading all technical development activities (from DNA to launch) for biologicals including process, pharmaceutical, and device development plus pilot plant operations. All these activities are tightly integrated in the design of the corresponding therapeutic biologicals molecule and lay the foundation of the future manufacturing process. Deep understanding of corresponding requirements (eg mode of action, efficacy/safety profile, CMC continuum aspects, Technical Regulatory, interaction with Health Authorities) and trustful interface management with Discovery experts on one hand and Operations on the other hand are key parts of my accountability. The position encompasses developing strategies for diverse topics as technology management, process platforms, process characterization concepts, Outsourcing or Operational Efficiency. Additional responsibility includes assigning resources to projects, communicating progress and issues to senior management, taking prioritization decisions, and establishing Biologicals portfolios that span across different indications and different modalities.

I’m responsible that project teams and subject matter experts define the right CMC strategies (Right in Time versus Right First Time, Risk taking versus Frontloading) as well as the right CMC packages for submission.