LIÈGE
Within these last years, I have developed strong abilities that have enabled me to successfully manage the R&D activities, supervise non-clinical studies, supervise IVD kit development, manage efficient transfer from R&D to GMP manufacturing, manage the production of products (Drug Substance and Drug Product) in full compliance with international GMP requirements and supervise the validation of analytical methods.
During my thesis in the genetic field, I performed experiments with Chlamydomonas reinhardtii, an unicellular organism, to understand the transmission of mitochondrial and chloroplast DNA.
As Ph.D. in Molecular Biology, I worked with Professor Andre Goffinet (Namur University) and with Professor Philippe Gros (McGill University, Montreal) in order to clone specific genes: reeler, a central nervous system gene and Lgn1, gene for natural resistance to infection with Legionella pneumophila. For these goals, I used RNA, cDNA libraries, BAC and YAC libraries. I did DNA extraction from mouse tails to establish the high-resolution linkage map in the vicinity of the Lgn1 locus.
While working for the Genetics Department of Veterinary, Liege University and the Center for Molecular and Vascular biology, department of Leuven University, I successfully applied my genetic research skills and I worked with bacteria, plasmid, sheep and human DNA.
Molecular technologies like PCR and qPCR were the routine experiments during the academic positions; please see my publications in the resume.
Between 2000 and December 2012, I worked at Eurogentec, a biotechnology company.
My first position was Team Leader of DNA sequencing. I was in charge of the laboratory setup and the management of all production projects. My team has been awarded of ISO9002 certification.
I was also implicated in the development of protein array and the QC tests. I am co-inventor of four patents.
Afterwards, as Product Development Manager, I was in charge of the development of new products and services for our customers (like Taq polymerases, qPCR mastermix, fast production of polyclonal antibodies (28 days instead of 3 months), proteins labeling).
Between 2013 and 2015, I worked at Uteron Pharma, a member of Actavis group, as Preclinical Manager. I was in charge of the management of several projects in a pharmaceutical complex environment with multi-disciplinary team. Moreover, I was implicated in the development of in-vitro diagnostic kit (ELISA assay) with CE mark until transfer to the production site.
Between 2015 and at the end of 2016, I worked at ASIT biotech, a biopharmaceutical company as Head of Production and GMP Tech Transfer (QC and manufacturing) Manager. I was responsible for leading highly-collaborative programs with different CMO for the production of products (API and final formulations) in full compliance with international GMP requirements and I also supervised the QC tests in accordance with the European Pharmacopoeia (Ph. Eur.) and the U.S. Pharmacopeial Convention (USP).
The final drug product manufacturing process validation has been successfully completed at a leading CMO who is approved by international health authorities including EMA (European Medicines Agency) and the US FDA (Food and Drug Administration).
Mes compétences :
Molecular Genetics
manage the product development team
good management skills
Quality Control
QC management
QA support
Product Development
Analysis skills
Manage the production
Tech transfer management
R&D and GMP manufacturing
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