Mes compétences :
optimization
Process
Process Optimization
Product Development
Scale up
Entreprises
Northstar Healthcare
- Technical Project Manager
2009 - maintenant
Fournier Laboratories Ireland
- Product Development Scientist
2005 - maintenantDevelopment of new solid oral dosage form.
• Optimisation of manufacturing processes.
Assistance with the cGMP manufacturing of clinical trial product using techniques of fluid bed granulation, high shear granulation, blending and compression in the pilot plant.
• Scale up and optimization to transfer technology from R&D to Manufacturing.
Assistance with the transfer of product from the pilot scale to the commercial scale.
• Submission of the CTD to the Authorities
Review of all process related to the batch records.
Analysis, interpretation of data and results.
Writing of Technical reports related to the formulation and process of the product.
Review of the Formulation and the Process section of the CTD dossier
SANOFI AVENTIS PASTEUR
- Process Scientist
Paris2004 - 2004Optimization of the robustness of the formulation of the Tetravac® vaccine
• Process troubleshooting and investigation: determination of the critical parameters of the process with Methodology Six Sigma
• Elaboration of a model with statistical analyses (have used Jump software)
• Elaboration of a design of experiments for mini formulations of the vaccine
• Manufacture lab-scale formulations for investigational work
• Interpretation of the results with statistical analyses
MERCK KGaA
- Analytical Chemist
Darmstadt2003 - 2003Study of the stability of the drug formulations
• Caracterization and qualification with HPLC methods of the impurities contained in the gelatinous capsules.
MERCK KGaA
- Organic Chemist
Darmstadt2002 - 2003Preparation of potential inhibitors in factors Xa and VIIa
• Planned and performed organic compounds multistep synthesis
• Purification by chromatography and interpretation of spectra NMR
