About me

I am a GMP Quality and Biotech professional with over 31 years´
experience within the Biotech/Pharmaceutical Industry, including 10 years’ “hands on” Biotech
process development and commercial manufacturing and over 21 years’ in different local and
global Quality positions at Novartis/Sandoz Biotech network. I am a German citizen
having lived and worked for the last 31 years in Europe and Singapore and am based in Germany.

I earned a Diploma in Biology and PhD in Applied Microbiology from University Ulm, Germany

Experience

I have extensive leadership experience in process development in Biotech Bulk DS manufacturing (microbial and
Cell culture) and in designing and building commercial manufacturing facilities in Europe and Asia (Singapore). I was leading
Quality positions in TRD and TechOps of Biopharmaceuticals overseeing multiple development and commercial sites in Europe,
US and Asia with multiple commercial products (NBE’s and biosimilars) in the market and multiple compounds in late phase
development.

As Global Head Quality Biotech Platform at Novartis/Sandoz I developed a track record in successfully preparing
teams and sites for inspections (regular inspection or PLI’s), towards all major international HA’s. I have extensive
practical experience in leading international cross-functional teams and task forces, e.g. integration projects, quality
remediation projects (Warning letter removal) and I have strong multicultural leadership experience, e.g. Europe, US and Asia.

Key Competencies

include Biotech Process Development and Characterization, Biotech Commercial Manufacturing,
Transformation of Development sites into GMP commercial sites, Facility design and Qualification, Equipment
Qualification/Validation, Regulatory Inspection Preparation & Management, in particular, the FDA and other Major Regulatory
Agencies, cGMP, QA Systems/Control, GMP Compliance,