20 years of experience in the biopharmaceutical industry, holding a phd in Pharmaceutical Technology from the University of ghent (belgium) and eu Qualified Person. at actogenix, managing the biopharmaceutical process and Formulation development, GMP Manufacturing runs, clinical Packaging and supply and qp release of all actobiotics™ investigational products based on the topact™ platform, for clinical studies in ibd (ulcerative colitis), oral mucositis, allergy etc... Qualified Person responsible for the release and certification of imps for use in Clinical trials.
Director CMC; Qualified Person
Since March 2010
responsible for making an active contribution, at a strategic level and in the day-to-day management of outsourced Manufacturing activities, to support supply of Biological drug candidates in early and late stage Clinical trials. coordinate and manage all Formulation and Process development, cGMP production and clinical Packaging and supply activities with external CMO partners. Qualified Person on behalf of the company in the release and certification of imps for use in Clinical trials. company Expert on all cmc-aspects of Biological Drug Development: playing a cross-departmental advisory and consultancy role regarding the cmc activities and manage CMO screening/selection and CMO contract negotiations. reporting to CEO Responsible for making an active contribution, at a strategic level and in the day-to-day management of outsourced manufacturing activities, to support supply of biological drug candidates in early and late stage clinical trials. Coordinate and manage all formulation and process development, cGMP production and clinical packaging and supply activities with external CMO partners. Qualified Person on behalf of the Company in the release and certification of IMPs for use in Clinical Trials. Company expert on all CMC-aspects of biological Drug Development: playing a cross-departmental advisory and consultancy role regarding the CMC activities and manage CMO screening/selection and CMO contract negotiations. Reporting to CEO
Manager CMC Regulatory Affairs, Qualified PersonJuly 2007 --- February 2010
coordinate and manage Process development, cGMP production, clinical Packaging and imp supply activities with external CMO partners: solve problems in collaborative teams, build consensus, implement solutions and act as the key cmc-contact for the third party contractors. act as Qualified Person on behalf of the company in the release and certification of imps for use in Clinical trials. guarantee appropriate quality and Compliance throughout all external cmc collaborations: review and approval of qa-agreements and responsible for external and internal cGMP Auditing.
Analytical thinkingInterest in knowledgeOptimismOrganizationPerspectiveProactivityProblem solvingReaction to stressSelf-confidenceService orientedInnovative thinkingIndependenceDiligenceAdaptabilityAssertivenessCharmAuthenticityCollaborationCoordinationCreative thinkingCritical thinkingCuriosityTrust
batch Lab scale batchesPilot scale batchesQuality Assurance (QA)OutsourcingcmoManaging Clinical Trial SuppliesCMCCMC Regulatory submissionsRegulatory affairsClinical Development R&D Phase IAllergy and immunologyAntibodiesBioavailabilityBiopharmaceuticalsBiotechnologyCell CultureClinical trial audits and inspectionsDrug development processDNA sequencingFDAGCPGastroenterologyGood Laboratory Practice (GLP)GMPGood Clinical Practice (GCP)IMPDINDPharmaceutical Industrypeople managementPhases of clinical development (phase I to IV)Project ManagementQualificationR&DWriting Study Procedures and SOPs
Skills and Expertise
Build the CMC development planChemistry Manufacturing and Controls (CMC) activitiesCoordinate CMC-activitiesPrepare CMC source documents Prepare CMC source documents related to clinical trial applicationBuild CMC development planRepresent CMC team Represent the CMC team in the cross-functional development teamResponsibility for the coordination of CMC-activitiesSelect and manage contractors executing the CMC – Chemistry action
in Certified Quality Assurance manager – Pharmaceutical production from European Compliance Academy in 2009
People management & leadership courses in from Mercuri Urval in 2007
in People management & Personalized Leadership from Dynargie in 2004
PhD in Pharmaceuticals from Ghent University in 1998
in Science from Koninklijk Atheneum Oostende in 1996
in from Conservatorium Oostende in 1995