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Summary

dedicated and consciencious, i really enjoy dealing with challenges. i like having a follow-up of a project from its very beginning until its logical end.

with more than 4 years experience in Pharmaceutical companies, i developped a real interrest in life science Chemistry.

Experiences

Current Experience

  • Project Manager

    Braine-l'Alleud, Belgique
    Since February 2013

    - single point of contact for international customers
    - managing a portfolio of several cmc projects (drug product and process transfer and/or development)
    - preliminary assessment activities: Risk Assessment, cost and investment assessment, Project Planning set-up (gant-chart), project team establishment, kick-off meeting with project team and with customer    
    - Project Management (cost-quality-timing) including multi-disciplinary activities coordination, planning follow-up, project actions and steps follow-up, regular meetings (project team and/or customer), issues trouble shooting,…
    - process Validation
    - support customer to regulatory filing (FDA, emea,…)
    - product life cycle management of commercial products (customers requests, audits, quality support, business review meeting,...)

    - Single Point of Contact for international customers
    - Managing a portfolio of several CMC projects (drug product and process transfer and/or development)
    - Preliminary assessment activities: Risk assessment, cost and investment assessment, project planning set-up (gant-chart), project team establishment, kick-off meeting with project team and with customer    
    - Project management (cost-quality-timing) including multi-disciplinary activities coordination, planning follow-up, project actions and steps follow-up, regular meetings (project team and/or customer), issues trouble shooting,…
    - Process validation
    - Support customer to regulatory filing (FDA, EMEA,…)
    - Product life cycle management of commercial products (customers requests, audits, quality support, business review meeting,...)

Past Experience

  • Phamaceutical consultant Bruxelles, Belgique

    October 2010 --- January 2013

    may 2011 – december 2012 (1 year 8 months)
    customer: baxter Healthcare as "product support Scientist"
    - r&d Nutrition projects coordination
    - follow up and coordination of sncs (supplier notification of changes)
    - follow up and coordination of Change Control


    novembre 2010 – may 2011 (7 months)
    customer: glaxosmithkline as "quality support to vaccine Formulation"
    - non conformity (deviations) handling (investigation and solving)
    - external complaint management
    - correctives and preventives actions (capa) management
    - small crisis coordination

Personality

Self Assessment :
TrustAuthenticityProblem solvingCollaborationIndependenceCuriosityOrganizationStrategic thinking

Knowledge

Self Assessment :
Biochemistry NegotiationBiopharmaceuticals R&DCancerCAPAChemistryData AnalysisFDAGood Manufacturing Practice (GMP)MATLAB (matrix laboratory)Microsoft OfficeMedical oncology Validation

Skills and Expertise

Self Assessment :
Manage projects resourcesCollaborate with project teamManufacture of non-GMP and GMP batchesCoordinate CMC-activitiesProtocols and reports writing

Training and Certification

  • Ms in Bioengineer in chemistry in 2010 Certification

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Locations I am interested in:
    Brabant Wallon, Belgium Germany Switzerland
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Brabant Wallon, Belgique

Others

Driving License
  • Yes

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