Marc Vandervost Email & Phone Number

Braine

- 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- Lead for technology transfer, process improvements and other key projects for commercial manufacturing

Braine

Worldwide batch certification of Drug Substance and Drug Product for the first marketed biotech product at UCB

Wavre, Belgium

- 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

- Definition and implementation of the technical program for development projects (formulation and/or lyo development), first GMP manufacture of clinical batches and transfer of production for sterile drug products: writing of manufacturing instructions and/or development protocols and reports, determination of equipments to be used and quality standards, control and guidance of production, proposal of solutions to technical problems, verification of results and documentation- Project Management: setting 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 stakeholders and customer, control of invoicing and budget, identification of risks and conflicts with response strategy for issue resolution, proposal of process optimization and costs reduction- Assessment of the feasibility and cost for development and transfer projects- Regulatory Affairs support for product development

Responsible of different R &D projects at an early development stage (first GMP batch) or at the (pre)validation stage for chemical synthesised peptides: - 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 customers- Set up and update of Gantt Chart capturing all dimensions and deliverables of the projects- Identification of the key issues affecting the project execution and proposal of solutions

- Responsible of new projects: first manufacturing or packaging of drug products (technical transfers), changes in manufacturing process, validation of sterilization process (e.g.: gamma irradiation, ethylene oxide sterilization)- Writing of manufacturing instructions (batch records) and validation documents- Preparation and submission of CMC variation files and contact person for Belgian Health Authorities- Back-up of the Qualified Person for the release on the market (Belgium and other EU countries) of drug products

Assistant at Lab. Instrumental Analysis and Bioelectrochemistry (Prof. Kauffmann)- 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

- 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

- 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 some of the most important products of the company’s portfolio- 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 for clinical studies and submission files

- Responsible pharmacist for the release on the Benelux market of Bournonville Pharma products - QA Manager : follow-up of GDP requirements for the warehouse, audits of subcontractors, writing and setting up of SOP,...- Regulatory Affairs responsible for Belgian, Dutch and Luxembourg Authorities- Scientific training of sales representatives- Scientific presentation to medical staff

Education record

Sciences and mathematics

Specialist, Industrial Pharmacy

Master, Pharmacy

Education record