Christian Bauer

Managing Director of the Cologne Site (+400 employees) a.i.. Production of Sanofi Consumer Health Care products for international markets.

Produktionsleitung für biotechnologische Wirkstoffe (Insuline) Leader of an APU (Autonomous Production Unit) organization (~250 employees (QA/QC/Engineering/Production), thereof ~150 employees in production) - 3 plants for Fermentation, Capturing, Chromatographic Purification and Infrastructure & Services to produce Insulin APIs Implementation of performance/productivity initiatives such as efficiency boosters to remain Best in Class, including close collaboration with Works Council.

Drive optimizations to increase productivity and performance at the Site by e.g. applying LEAN and SixSigma tools, continuous process improvement activities and best practices. Project management activities (steering, project or program lead, Task Force lead) with focus on financial target achievements. Creation of a KPI reporting and escalation/cascading system to monitor and manage the performance at Site. Member of the Site Leadership Team and direct reporting to Site Head.

Development and realization of quality assurance, quality control and regulatory strategies to assure the quality of drug substances. Development and harmonization of strategies within Sanofi sites. Support of regulatory inspections. Identification, analyzation and optimization to improve current GMP, regulatory, quality assurance as well as quality control practices. Direct reporting to Site Quality Head.

Microbiological Quality Assurance with respect to management of Validation/Qualification/Monitoring of clean rooms, water and pure steam systems, sterilization of equipment. Deviation, Alert/Action Level and Change Control handling. Assessment of micobiological quality of Insulin drug substance. Benchmarking activities within BioPhorum Operations Group (Bioburden workstream). Management, lead and support of internal projects.

Responsible for regulatory compliance of insulin and oligo peptide drug substances. Responsible for the coordination and preparation of global pharmaceutical, chemical and biological documentation (CMC) for international registration purposes and maintenance of marketing authorizations including all CMC for insulin and oligo peptide drug substances of marketed products for worldwide regulatory submissions (e.g. approvals, registration renewals and variations to marketing authorizations).

Project Management, Sanofi-Aventis Deutschland GmbH, Lantus API plant capacity increase with focus on validation/qualification of clean room, water and pure steam systems as well as sterilized equipment.

Mikrobiologie, Genetik, Spezielle Zoologie