Qualifications

Over twenty five years broad ranging pharmaceutical industrial experience as a Qualified Person with extensive management responsibilities for synthetic and biological activities, parenteral, oral and over the counter drugs. Skills range broadly, covering areas such as plant design, plant start-up, optimization of plant operations, personnel training, submission and maintenance of regulatory filings, qualification of contract manufacturers. Extensive experience with EU and FDA inspections.

Specializing in conceptual plant design and start-up, staff training, compliance, evaluation and remediation, operational optimization and European filings.

Merz Pharma GmbH & Co. KGaA

Responsible for management of the Merz Reinheim, Oldenwald and Dessau plants. Total 160 FTEs. Responsibilities included In-house and Contract Manufacturing, Engineering, Total Quality Management, Technical Services, Quality Control, Environmental Protection and Operational Safety. Conducted extensive GMP upgrades of the Reinheim drug product plant. Developed design concepts, implemented engineering and construction oversight for a new very high potency biologic API and parenteral manufacturing drug product plant in Dessau using isolator technology, approved by EU authorities in 2009, FDA in 2010.

Increasingly responsible positions, culminating as Head of Pharmaceutical Production, responsible for production at the Künsebeck and Dresden locations, producing oral, inhalation and sterile dosage products. At the corporate level was responsible for production oversight at eight world-wide locations. Responsible for management of a new facility using isolator technology for production of cytostatics from the APIs to the finished parenteral dosage products.

Ph.D. (Pharmaceutical Technology)

Pharmacy Degree

Friedrich-Alexander-University, Erlangen