Dr. Harald-Gerhard Geppert
Angestellt, Director Regulatory Affairs, Head of Regulatory Operations, CMRA, QIAGEN GmbH
Hilden, Deutschland
Werdegang
Berufserfahrung von Harald-Gerhard Geppert
Bis heute 1 Jahr, seit Juni 2023
Director Regulatory Affairs, Head of Regulatory Operations, CMRA
QIAGEN GmbHBis heute 3 Jahre und 2 Monate, seit Apr. 2021
Associate Director, Medical Safety Lead, CMRA
QIAGEN GmbHREGULATORY AFFAIRS (IVDR 2017/746, 98/79/EC, etc.) in the context of in vitro diagnostic medical devices
REGULATORY AFFAIRS (focus: 93/42/EEC, 98/79/EC, MPG, DIN EN ISO 13485, DIN EN ISO 14971, 21CFR820, FDA regulations) in the context of in vitro diagnostic medical devices
REGULATORY AFFAIRS (focus: 93/42/EEC, 98/79/EC, MPG, DIN EN ISO 13485, DIN EN ISO 14971, 21CFR820, FDA regulations) in the context of in vitro diagnostic medical devices
REGULATORY AFFAIRS (focus: 93/42/EEC, 98/79/EC, MPG, FDA regulations) and quality management representative (focus: DIN EN ISO 13485, DIN EN ISO 14971, 21CFR820) in the context of in vitro diagnostic medical devices, safety officer (MPG)
2 Jahre und 7 Monate, Jan. 2007 - Juli 2009
Manager Therapeutic & Clinical Applications
mosaiques diagnostics GmbHBUSINESS DEVELOPMENT (focus: establishment of business connections, writing of press releases, news letters, publications, presentations, supervision of internet presence), contract negotiations and direction of studies in cooperation with the pharmaceutical industry
4 Jahre und 4 Monate, Sep. 2002 - Dez. 2006
Project manager (Antibody generation and Target validation)
GANYMED Pharmaceuticals AG
DEVELOPMENT and CHARACTERISATION of POLYCLONAL and MONOCLONAL ANTIBODIES, immunization of mice and rabbits, hybridoma techniques, recombinant protein production (bacterial, in vitro translation, mammalian cells), chromatography, assay development (focus: immunofluorescence microscopy, ELISA, WB), cell and tissue culture, project management, reporting, safety officer
Ausbildung von Harald-Gerhard Geppert
Cellular Biochemistry and Biophysics Program
Cornell University - Memorial Sloan Kettering Cancer Center
Expression systems, animal models, cell and tissue culture
Clinical research unit
Munich Technical University - University hospital rechts der Isar
Expression systems, cell and tissue culture, confocal immunofluorescence microscopy
Department of Chemistry/Biochemistry
University of Bielefeld
Cloning, gene expression, recombinant protein expression systems (E. coli, P. pastoris, Mammalian cells), chromatography, development of polyclonal antibodies, assay development, cell and tissue culture
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