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Summary

PROFILE: Master in the chemistry/biochemistry with extensive experience in complex and international programs in the pharmaceutical and biotechnology industries: 25+ years of experience in project management of analytical development activities (method development, validation and transfer, product characterization, release and stability testing) including regulatory filings, chemical processes, new product introductions, change control, process validation, specification management of API´s/drug products/vaccines and quality assurance. SKILLS: Project management skills, communication skills, excellent organizational and planning skills, quality and result oriented, analytical and structured person. SPECIALTIES: Project Management/CMC Method Development/Validation/Specification Management Visual Workflow and Risk Management Technology Transfer/New Product Introduction Process validation Change Control Quality assurance cGMP and ICH guidelines

Experiences

Current Experience

  • Senior consultant - Analytical Technical Integrator
    Since June 2015
    As Analytical Technical Integrator in the Analytical Development department, I am responsible for developing analytical project strategy, managing planning and execution of analytical deliverables and coordinating project transfer between phases (early, late development and commercial launch) of vaccine projects, including supporting regulatory filings.

Past Experience

  • Senior consultant - PDMS Lifecycle Management & Specifications
    January 2015 --- June 2015
    Project lead for the implementation of the ICH Q3D guideline for elemental impurities. Project manager for leading and coordination project teams within the analytical organization.

  • Interim Manager - Technical owner PDMS Lifecycle Management & Specifications
    July 2011 --- December 2014
    Responsible for the maintenance/oversight of all legacy specifications (drug substance and drug product) and methods (coordination and first line support) for small molecules. Central point of contact for analytical project information. Project manager for leading and coordination project teams (internal and external experts) within the analytical organization. Project lead for the implementation of the EMA guideline for metal impurities.

  • Senior Consultant - Business Excellence Engineer
    April 2011 --- June 2011
    Item optimalization project concerning raw materials and supporting pharmaceuticals.

  • Senior Consultant - QA Compliance F&E
    October 2010 --- February 2011
    Review and approval of validation (equipment), calibration and maintenance documents, follow-up on deviations, CAPA´s, change control, review and approval of procedures, protocols and reports. Follow-up on correct implementation of the guidelines.

  • Senior Consultant - Analytical Inspection Readiness Program Coordinator
    February 2010 --- September 2010
    Lead of a project team that prepares the analytical part of a new product. Coordination of the pre-approval inspection readiness program for the QC-lab.

  • Senior Consultant - QA Compliance for QC
    June 2009 --- January 2010
    Teamlead QA/QC. Coordination of the activities required to meet the quality standards for the QC environment: follow-up on deviations, CAPA´s, leading the QC-investigations, change control, internal audits, review and approval of procedures, protocols, reports, stability documentation. Follow-up on correct implementation of the guidelines.

  • Manager Change Control
    April 2008 --- May 2009
    Expert in change control for chemical process changes. Define impact assessments and actions on different areas (regulatory, analytics, validation status, EH&S, logistics, stability, documentation). Central contact person for Chemical Production Belgium for process change control for the Wordwide Chemical Production Sites within J&J.

  • Project Manager New Process Introductions
    January 2002 --- March 2008
    Project Manager for leading multidisciplinary project teams in an active pharmaceutical ingredient (API) production facility. This function included technology transfer activities, introduction of new chemical processes, process validation and scale-up according to cGMP, EH&S, quality and compliance guidelines and fulfil the standards for process-robustness and cost-conscious. Collaborate on preparation of the chemical part of the regulatory dossier and preparation of pre-approval inspections.

  • Validation and System Engineer
    January 2001 --- December 2001
    Validation of commercial chemical processes Equipment qualification Cleaning validation

  • Project Leader Specification Management Chemicals
    May 1997 --- December 2000
    Management of the analytical product specifications for the purchased chemical products, the intermediates, the active pharmaceutical ingredients (API) and the plant and material protection products for the worldwide chemical production of J&J.

  • Quality Assurance Associate
    April 1992 --- May 1997
    Implementation of a quality system according to the GMP standards for the chemical production sites in Belgium (Geel/Beerse). Batch record review, deviation handling, product release, review and writing of procedures, audits, training. QA-person in all kind of projects.

  • Quality and Sterility Expert
    July 1990 --- March 1992
    Implementation of a quality system according to the GMP standards for assembling, packaging, sterilisation and distribution of medical devices.

Personality

Self Assessment :
Analytical thinkingApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCritical thinkingFlexibilityProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineService orientedTrustStrategic thinking

Knowledge

Self Assessment :
Biochemistry Phase I R&D21 CFR Part 11Analytical ChemistryAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesApplicationsAssay developmentBudget ProcessCAPAcGMPChange ControlChange ManagementCharacterizationChemistryChemistry, Manufacturing, and Controls (CMC)ChromatographyCMCCommunication SkillsCompetitive AnalysisComplianceCompliance with regulationsContinuous ImprovementCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Drug substancesEarly development stageEnglishFailure Mode and Effect Analysis (FMEA)FDAgas chromatographyGMPGood Manufacturing Practice (GMP)ICH guidelinesIMPDINDKnowledge of the drug development processLife SciencesManagement ConsultingMarketing Authorisation Application (MAA)Microsoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMitigationMS ProjectNew Drug Application (NDA)Organic ChemistryOutlookOutsourcingPharmaceutical IndustryPharmaceutical DevelopmentPhases of clinical development (phase I to IV)Position PaperPowerPointProblem SolvingProject CoordinationProject ManagementProject PlanningProtocolQA complianceQC releaseQualificationQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality ManagementQuality Management System (QMS)Quality SystemsRegistration of the productRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory StrategiesRegulatory submissionsReport WritingRisk AssessmentRisk ManagementRoot Cause Analysis (RCA)SAPSmall moleculesStability testsStandard Operating Procedure (SOP)SterilizationStrategyStudy protocolsTeam BuildingTeam LeadershipTeam ManagementTeamworkTechnology transferUnderstanding of regulatory guidelinesValidationVaccines
LinkedIn Assessment :
GMPValidationChange ControlV&VPharmaceutical IndustryTechnology transferSpecification managementICH guidelinesQuality ManagementProject Management21 CFR Part 11

Skills and Expertise

Self Assessment :
Analytical skills Build the CMC development plan Create SOPsAdvise on strategyAssess product quality issuesAssess quality process issuesAssign activitiesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with proceduresAttend at steering committee meetingsAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesChemistry Manufacturing and Controls (CMC) activitiesCollaborate with project teamCommunicate effectively on different company levelsCommunicationCoordinate CMC-activitiesCoordinate projectsCreate SOPsCreates a collaborative team environmentDevelop Quality Risk Management (QRM) initiativesEstablish professional relationships with partnersEvaluate stability data and impurity identification/synthesisExecute internal/external quality assurance assessmentsFollow-up of external auditsFollow-up of internal auditsFollow up training programsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGastrointestinal diseasesImplement Quality Management System (QMS)Interpret analytical resultsLate-stage regulatory filing (MAA, BLA)Lead teamsMaintain Quality Management System (QMS)Maintain strong relationshipsManage complexityManage global quality standardsManage laboratory proceduresManage multiple projectsManage projects resourcesManage Quality Management System (QMS) documentationManage risksmanaging a small teamMonitor Key Performance Indicators (KPI's)Organise meetingsOral presentationOrganise steering committeePrepare CMC source documents Prepare responses to health authority queriesPresent at steering committeeproject managementRegulatory documentationRegulatory submissionsRelease productsRepresent CMC team Review protocolsReview manufacturing documentationReview quality control activitiesReview quality policiesReview reportsReview study protocolsReview the interpretation of dataSolve problemsWork cross-functionallyWrite documentsWriting regulatory documentsWritten presentation

Education

  • Master in Biochemistry from Katholieke Hogeschool Limburg in 1988
  • Master in the chemistry - biochemistry in from Katholieke Hogeschool Limburg in 1988

Training and Certification

  • FPX Project Leader in 2015 Training
  • Visual Workflow and Risk Management in 2015 Training
  • Project Management in 2004 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Professional Proficiency
    Dutch
    Native
    French
    Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Management Consultant Senior Consultant CMC Project Manager Compliance Manager Project Manager Project Leader QA Consultant QA Engineer QA Lead QC/QA Manager Quality Assurance (QA) Manager Quality manager Regulatory Project Manager Regulatory Affairs Consultant Senior Project Manager (PM)
  • Locations I am interested in:
    Belgium Nederland
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week :    100 % Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Lichtaart, Kasterlee, Belgium

Others

Driving License
  • Yes