Technology Development Leader for the Thermostability Program
Since January 2014
▪ Definition of program strategy, priorities, timelines, budget and resources. ▪ Planning, supervision and coordination of program activities. ▪ Management of meetings and teleconferences. ▪ Reporting (including financial reporting) to Management and external funding organizations. ▪ Day-to-day management of external collaborations (due diligences, agreements, transfers of materials and information, presentation of results, writing of reports) and grants. ▪ Risk management.
Head of Drug Product Technologies
Since January 2014
▪ Identification, evaluation and development of advanced technologies for vaccine manufacturing, stabilization and delivery through the intramuscular/subcutaneous, oral, intranasal and intradermal routes. ▪ Leader or member of several cross-functional teams (Project Teams, Technical Teams). ▪ Leader of a working group that manages Intellectual Property aspects inside Technical R&D - Drug Product (freedom to operate, new applications). ▪ Knowledge Management around classical and new excipients. ▪ Member of the Technical R&D Innovation Management Team, a committee that evaluates the potential of new technologies for vaccine development and manufacturing. ▪ Day-to-day management of the team of Scientists (budgets, timings, capacity and performance management).
Expert Scientist, Head of Drug Product Development for Bacterial Vaccines
January 2010 --- December 2013
▪ Development of the formulation process of various vaccines (liquid and freeze-dried, adjuvanted and non-adjuvanted formulations), from the Discovery stage to the transfer to the Manufacturing facilities (including preformulation studies, stress tests and characterization tests, development of preclinical and clinical formulations, definition of the Process Analytical Technology strategy and participation to the definition of the release specifications, evaluation of the manufacturability, production of reproducibility lots, scale-up, PE/PV, trouble-shooting and support to life-cycle activities), in alignment with relevant regulatory guidance and using the principles of Quality by Design, as well as Design of Experiments. ▪ Redaction and review of protocols, methods of production, development reports and patent applications. ▪ Redaction of some paragraphs of the IND application, of the Investigator's Brochure and of the CMC part of the file. ▪ Preparation of inspections, participation (by phone) to various regulatory meetings (Type-C meeting, consultation with the PEI…) and answers to eventual questions from the Authorities. ▪ Leader of one Technical Team for 3 years; this project aimed at developing a drug-device combination including a dual chamber syringe. ▪ Member of several Technical Teams. ▪ Day-to-day management of the team (Scientists, Lab Technicians).
Scientist, Formulation of bacterial vaccines
December 2001 --- December 2009
▪ Development of the formulation process of all bacterial vaccines (recombinant proteins, particulate antigens, polysaccharides conjugated to carrier proteins), from the Discovery stage to the Phase 1/2 (including development of preclinical and clinical formulations, stress tests and characterization tests, manufacturing of reproducibility lots, in alignment with relevant regulatory guidance. ▪ Redaction of protocols, methods of production, development reports and patent applications. ▪ Redaction of some paragraphs of the IND application, of the Investigator's Brochure and of the CMC part of the file and answers to eventual questions from the Regulatory Authorities. ▪ Member of several Project Teams and Technical Teams. ▪ Day-to-day management of the team (Lab Technicians).
Regulatory Affairs Associate Berchem (Antwerp)
September 1999 --- December 2001
▪ Preparation and submission of the marketing authorization renewal applications for all products and elimination of the backlog in the registration and variation files of the veterinary products. ▪ Management of registration, price and reimbursement files of a part of the portfolio of medicines for human use. ▪ Management of registration and price files for all veterinary products. ▪ Preparation of the part of the file corresponding to current Module 1 and submission of the registration and variation files through the national and decentralized procedures. ▪ Coordination and verification of the translation of the SmPC, labelling and package leaflet (from English to Dutch, French and German). ▪ Interactions with Belgium and Luxembourg Ministries of Health, Economics and Social Affairs; SPoC for the Luxembourg Authorities, for all products. ▪ Participation to the set-up of a new SAP-based regulatory database called "MedReg".
Pharmacist Brussels, Belgium
July 1998 --- August 1998
Several interim positions
FlexibilityInnovative thinkingCreative thinkingWillingness to compromiseAdaptabilityAttention to detailCollaborationOrganizationProblem solvingResiliencyResult OrientedAssertivenessAnalytical thinkingCuriosityCommunicativeCoordinationIndependence
Skills and Expertise
Build the CMC development plan Analytical skills Develop protocols Lab scale batches Technology research Write protocolsWritten presentationWrite papersWrite documentsWork cross-functionallyTranslate strategy into operational plansSupport due diligence assessmentsSupervise techniciansSupervise PhD studentsSubmit regulatory applicationsSolve problemsSet up research projectsReview protocolsReview manufacturing documentationResearch at universitiesReport Key Performance Indicators (KPI's)Regulatory submissionsRegulatory documentationRead medical literature to maintain current awareness and knowledgeR&DProvide support for scientific and/or technical projectsProvide input to process improvement initiativesproject managementPresent data at congressPresent at steering committeePlan work to meet objectives and deadlinesPlan experiments
Diplôme d'Etudes Complémentaires (1 year post-Master) in Business Administration and Management, General from Louvain School of Management in 1999
Master’s Degree in Pharmaceutical Sciences (specialization in formulation) from Université catholique de Louvain in 1998
Expert has 4 publications (Will be avalible with full profile)