Christian Bauer
Angestellt, Site Head Cologne a.i., A. Nattermann & Cie. GmbH / Sanofi
Köln, Deutschland
Werdegang
Berufserfahrung von Christian Bauer
Bis heute 1 Jahr und 9 Monate, seit Okt. 2022
Site Head Cologne a.i.
A. Nattermann & Cie. GmbH / Sanofi
Managing Director of the Cologne Site (+400 employees) a.i.. Production of Sanofi Consumer Health Care products for international markets.
1 Jahr und 9 Monate, Feb. 2021 - Okt. 2022
Head of Lantus API manufacturing
Sanofi-Aventis Deutschland GmbHProduktionsleitung 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.
2 Jahre und 9 Monate, Juni 2018 - Feb. 2021
Manufacturing Excellence Division Leader
Sanofi-Aventis Deutschland GmbH3 Jahre und 1 Monat, Mai 2015 - Mai 2018
Head of Manufacturing Excellence
Sanofi-Aventis Deutschland GmbHDrive 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.
1 Jahr und 7 Monate, Okt. 2013 - Apr. 2015
Head of Biotech Compliance & Projects
Sanofi-Aventis Deutschland GmbHDevelopment 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.
2 Jahre und 11 Monate, Nov. 2010 - Sep. 2013
Quality Manager Microbiology
Sanofi-Aventis Deutschland GmbHMicrobiological 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.
3 Jahre und 2 Monate, Sep. 2007 - Okt. 2010
Regulatory Compliance Officer
Sanofi-Aventis Deutschland GmbHResponsible 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).
11 Monate, Nov. 2006 - Sep. 2007
Project Manager
Ingenieur Büro Längle & Büchner GbR
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.
Ausbildung von Christian Bauer
7 Jahre, Okt. 1999 - Sep. 2006
Biologie/Sportwissenschaften
Technische Universität Darmstadt (TU Darmstadt)
6 Jahre und 3 Monate, Okt. 1999 - Dez. 2005
Biologie
Technische Universität Darmstadt (TU Darmstadt)
Mikrobiologie, Genetik, Spezielle Zoologie
Sprachen
Englisch
Fließend
Französisch
Grundlagen
Deutsch
Muttersprache
Russisch
Grundlagen