Agnes Goris (born 1961, Belgian citizen) has a Master Degree in Biology and a Postgraduate Degree in Biotechnology. She has 16 years of experience in the In Vitro Diagnostics and Biotechnology industries and held positions in R & D and Quality Control.
1999 - 2001 : Pharming N.V. (later Genzyme Flanders N.V.), Belgium
Head of Quality Control
Pharming N.V. developed and produced a recombinant drug in transgenic rabbits.
- Release of batches for clinical trials.
- Method validation
- Stability testing
- DNA screening for transgenicity
- Development of sampling plans for raw materials and in-process testing.
1994 - 1999 : Innogenetics N.V., Belgium
Mgr. Quality Control (1998-1999)
- Implementation of Method Validation,
- Implementation of Statistical Process Control
- In charge of Final QC of In Vitro Diagnostics r
Design Validation Officer in the QA/RA department (1997-1998)
- Validation of new diagnostic assays (according to ISO9001 and 21CFR820
- Compilation of European registration files
Scientific collaborator in the Development department (1994 - 1996)
- Development of diagnostic assays for HIV and HCV
1986 - 1994 Sanofi Diagnostics Pasteur, Belgium and France
Project leader and Research Assistent, R&D department R&D
- Development of immunodiagnostic assays for microbial markers
- Development and characterisation of monoclonal antibodies
- In vitro and in vivo culture of animal cell lines.
- Antigenic and immunological analysis of bacteria, fungi and yeasts
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