Christian Simon Email and Phone Number
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Christian Simon is a Head of Technical Transfer External Manufacturing @ Sanofi | Expertise in Drug Manufacturing at Sanofi. He possess expertise in pharmaceutical industry, fda, validation, gmp, regulatory affairs and 8 more skills. He is proficient in Englisch.
Sanofi
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Head Of Technical Transfer External ManufacturingSanofi Jul 2017 - PresentParis, France, FrAccountable for successful management of transfers of medicinal products and devices, in-time and in quality to CMOs (Contract Manufacturing Organizations), from CMOs and between CMOs.Lead international and interdisciplinary transfer project teams with CMOs: localization, CMO network rationalization, continuous improvement processLead the technical support for trouble shooting activities in CMOsLead detailed feasibility and financial assessments of transfer ideas resulting in transfer proposal and reach the endorsement by the corresponding decision committees (notably Sourcing).Develop comprehensive project plans (incl. resource planning) based on project order and feasibility studies. Monitor and report project progress.Determine budget for transfers and assume responsibility for budget adherence.Prepare and negotiate Transfer Agreement with CMOContinuously improve the transfer business process in close cooperation with all global functions
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Project Leader Transfer-In Insulin / Drug-Device CombinationSanofi Aug 2015 - Jun 2017Paris, France, Fr
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Project Leader Transfer Toujeo / Drug-Device CombinationSanofi Mar 2012 - Jul 2015Paris, France, FrProject leader for the industrialization of insulins transferred from research and development or other locations, and for lifecycle management initiatives.Planning and development of industrial manufacturing processes for new drugs.Interface between the relevant departments in the field of research and development (R & D), production (Industrial Affairs), global management functions and external partners.Planning and tracking of schedules and budgets.Evaluation of the feasibility of the production transfer requests.Review of submission documents (IND / IMPD / MAA / NDA).Advice regarding cGMP and regulatory guidelines and new technologies (process validation, single-use equipment).Implementation of risk management tools in the project environment.
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Project Manager Transfer Projects Ru, Cn Device ManufacturingSanofi Jan 2010 - May 2012Paris, France, FrResponsibility for the transfer of pen production to Russia and China.
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Supplier Manager Ch, Fin, FSanofi Jan 2005 - Dec 2009Paris, France, FrResponsibility for the external production of pen injector components at suppliers."Focal point" for supplier activities in Frankfurt.Technical support for ComOps for training, instruction and training materials.
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Plant ManagerSanofi Dec 2001 - Dec 2004Paris, France, FrResponsibility for the large scale production of insulin.Management of assets (availability, process optimization).Planning and control of insulin production under the consideration of quality, cost and ecological framework.Optimization of chromatographic processes on an industrial scale.A member of multidisciplinary teams for product improvement.Personnel Management (10 employees).
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Project ManagerSanofi Jan 1999 - Dec 2001Paris, France, FrCommissioning, qualification and validation of equipment and processes forlarge scale production of insulin.Process Optimization.Project Management.Development of a new process for drying insulin with the FIMA centrifuge dryer.Team member for product improvement.Allocation of human resources.
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Head Of Analytical LaboratorySanofi Jan 1995 - Dec 1998Paris, France, FrLead of the Chemical and Analytical Laboratories.Ensure the GMP-compliant development and implementation of analytical proceduresfor biochemical applications (HPLC, enzymatic assays, spectroscopic methods)and automation.Responsibility for the implementation of SAP/R3.Responsibilty for the emergency response organization.Advanced training concepts and implementation in the context of GMP and ISO 9001 for theproduction.Personnel Management (3 employees).
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R&D Manager FermentationHoechst Marion Roussel Inc. Jan 1990 - Dec 1994Responsibilty for the fermentation department (engineered E. coli K12 and natural microorganisms).Planning / coordination of the overall fermentation processes and personnel.Data analysis and statistical processing.Personnel management for 18 employees.
Christian Simon Skills
Christian Simon Education Details
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Fachhochschule DarmstadtRisk Management -
Leipzig UniversityFachingenieur Analytik+Spektroskopie
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Technische Universität DarmstadtChemical Engineering
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Paul-Ehrlich-School FrankfurtChemical Technology/Technician
Frequently Asked Questions about Christian Simon
What company does Christian Simon work for?
Christian Simon works for Sanofi
What is Christian Simon's role at the current company?
Christian Simon's current role is Head of Technical Transfer External Manufacturing @ Sanofi | Expertise in Drug Manufacturing.
What is Christian Simon's email address?
Christian Simon's email address is cs****@****ail.com
What schools did Christian Simon attend?
Christian Simon attended Fachhochschule Darmstadt, Leipzig University, Technische Universität Darmstadt, Paul-Ehrlich-School Frankfurt.
What are some of Christian Simon's interests?
Christian Simon has interest in Science And Technology, Education.
What skills is Christian Simon known for?
Christian Simon has skills like Pharmaceutical Industry, Fda, Validation, Gmp, Regulatory Affairs, Clinical Trials, Biotechnology, Medical Devices, Sop, Capa, Pharmaceutical Sales, Regulatory Submissions.
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