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UCB
- CMO Manager Pharma
COLOMBES
2015 - maintenant
Operational management of Contract Manufacturers for UCB strategic drug products
Leader of UCB Vendor team with members of Supply Chain, Quality Assurance and Global support functions (analytical, business alliance, packaging development,…)
Project leader for technology transfer, process improvements and other key projects
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UCB Pharma SA
- Qualified Person
COLOMBES
2011 - 2014
Qualified Person for the first biological UCB Pharma product: worldwide batch disposition of Cimzia drug substance and drug product for commercial purposes.
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GlaxoSmithKline Biologicals
- Project Manager Manufacturing Center of Excellence, Secondary Operations
Marly-le-Roi
2010 - 2011
- Task force leader for the mapping of filling lines for vials and syringes for all GSK Bio production sites
- Responsible for 2 projects related to major technical issues at the filling step for a vaccine and an adjuvant
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Nextpharma
- Project Manager Sterile Product Development
2007 - 2010
- Assessment of technical feasibility and cost for early phase development projects and manufacture of drug products for clinical trials (eg: first manufacture of cytostatic drug products for human administration)
- Project Management: set up of project plans and timelines, coordination activities, day-to-day follow-up and reporting of project status, lead of core team, communication with internal and external stakeholders, control of budget, …
- Design and implementation of experiments based on customers needs, technical supervision and guidance, identification of process optimization and costs reduction
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Lonza Braine SA (previously UCB-Bioproducts - Braine-l’Alleud)
- Project Manager R&D
2006 - 2007
Responsible of different complex R &D projects at an early development stage (first GMP batch) or at the (pre)validation stage : coordination of the activities across all functional areas (R&D, QA, QC, RA, supply) involved in a project, management of the overall project communication with the (US) customers, set up and update of Gantt Chart capturing all dimensions & deliverables of the projects , identification of the key issues affecting the project execution, ....
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ERFA SA (Belgium)
- Product Development & Regulatory Affairs Manager
2003 - 2006
- Responsible of new projects : first manufacturing,
first packaging of new products, change in manufacturing process, validation of sterilization process (gamma irradiation, ethylene oxide sterilization,...)
- Preparation and submission of variations (CMC section)
- RA support for customers
- Deput Qualified Person : Release on the market (Belgium and other EU countries)
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Lab. Instrumental Analysis and Bioelectrochemistry - ULB
- Research Assistant
2001 - 2003
- Contribution to the development of new technics of Electrophoresis Capillary (Electroinjection, EMMA) for the determination of the interaction between drugs and blood proteins (mainly albumin)
- Development of a new semi-permanent coating for Electrophoresis Capillary
- Charge of teaching for first licence students : laboratory and seminars in instrumental analytical chemistry and inorganic chemistry
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UCB Pharma SA
- Clinical Research Associate
COLOMBES
2000 - 2001
- Clinical Research Associate for the follow-up of one international multicentric clinical phase III study in allergy
- Clinical Trial Manager Associate for an international multicentric clinical phase III study in rheumatology
- Clinical Trial Manager for an international multicentric genetic study in allergy
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UCB Pharma SA
- Drug Regulatory Affairs Associate
COLOMBES
1996 - 2000
- Preparation of a full chemical-pharmaceutical file (CMC section) for a new research molecule
- Update, variation files (with expert reports) and response files (to worldwide authorities) for the CMC section of one of the main ucb Pharma product
- Contribution to the preparation of revalidation files for the clinical part of one of the main ucb Pharma product
- RA revision of protocols and reports of phase I, II and III clinical studies
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Bournonville Pharma SA (Belgium)
- Qualified Person
1995 - 1996
- Release on the benelux market of Bournonville Pharma products
- Responsible for RA activities
- QA Manager : follow-up of GDP requirements for the warehouse, audits of subcontractors, writting of SOP,...
- Regulatory Affairs contact person for the Belgian, Dutch and Luxembourg Authorities
- Scientific training of sales representatives
