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.
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,...)
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
TrustAuthenticityProblem solvingCollaborationIndependenceCuriosityOrganizationStrategic thinking
Biochemistry NegotiationBiopharmaceuticals R&DCancerCAPAChemistryData AnalysisFDAGood Manufacturing Practice (GMP)MATLAB (matrix laboratory)Microsoft OfficeMedical oncology Validation
Skills and Expertise
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