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Summary

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.

Experiences

Current Experience

  • 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

Past Experience

  • Manager CMC Regulatory Affairs, Qualified Person

    July 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.

  • Manager Product Development

    January 2002 --- January 2007
    Pharmaceutical and analytical development analytical Validation pilot batch production and Process development stability studies team Leader (9 direct reports)

  • Product Development Supervisor

    January 1998 --- January 2002
    Pharmaceutical Development analytical development and Validation stability studies

  • Researcher, PhD student

    January 1993 --- January 1998
    ph.d. thesis : "evaluation of maltodextrins as excipiënts in the Formulation of freeze-dried Pharmaceutical dosage forms".

  • Pharmacist

    July 1993 --- August 1993
    Pharmacist in a Pharmacy in belgium

Personality

Self Assessment :
Analytical thinkingInterest in knowledgeOptimismOrganizationPerspectiveProactivityProblem solvingReaction to stressSelf-confidenceService orientedInnovative thinkingIndependenceDiligenceAdaptabilityAssertivenessCharmAuthenticityCollaborationCoordinationCreative thinkingCritical thinkingCuriosityTrust

Knowledge

Self Assessment :
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
LinkedIn Assessment :
GMPDrug DevelopmentBiopharmaceuticalsPharmaceutical IndustryCMCFormulationRegulatory affairsGood Laboratory Practice (GLP)Formulation developmentPharmaceuticalseCTDQuality Assurance (QA)Stability StudiesINDCMC Regulatory AffairsQuality ManagementOutsourcingDrug DeliveryLyophilizationFermentation TechnologyAuditingReleaseIMPClinical ManufacturingClinical SuppliesCMO managementStability ProgramsIMPDCMC developmentOutsourcing ManagementQuality AuditingSupplier QualityBiotherapeuticsGood Distribution Practice (GDP)Cold ChainSupplier Quality ManagementContract ManufacturingBiotechnologyBiotechnology IndustryGCPDue DiligenceDeal DevelopmentOut-licensingPharmaceuticsVaccines

Skills and Expertise

Self Assessment :
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

Education

  • 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

Area / Region

Ghent, Belgium

Others

Driving License
  • Yes

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