2016 - maintenant- En charge des études de développement analytique pour la caractérisation, le développement et la validation de méthode en vue de leur application au contrôle qualité des lots de vaccins.
- évaluation des différentes options techniques permettant de contrôle des points critiques du procédé et d’assurer la comparabilité des lots au cours des différentes phases de développement
- interaction avec les départements internes de la R&D ainsi qu’avec les sous-traitants externes dans les domaines analytiques et production GMP.
- participation aux validations des techniques analytiques et à la supervision des études sous-traitées.
Généthon
- Ingénieur en développement d'analyses physico-chimiques
Ivry2011 - 2015Analytical and physical characterization of Adeno-Associated vectors (AAV) and Lentivirus vectors
Implementation, development, optimization and running the analytical techniques used in protein / vector / transgene (DNA) characterization : Analytical Ultracentrifugation, HPLC ( RP, IEX, IA), Dynamic Light Scattering, Electrophoresis, southern blot.
Design of rational approaches to investigate and understand AAV and Lentivirus physicochemical properties and stability to support bioprocess and product development, preclinical and early stage clinical studies.
Design and transfer methods to Quality Control after writing the Standard Operating Procedures.
Genethon
- Technicienne qualifiée de laboratoire
Ivry2009 - 2010
Laboratoires Pierre Fabre
- Stagiaire Développement analytique
Castres2008 - 2008Etude de la compatibilité physico-chimique entre des formulations injectables type et des dispositifs de perfusion
Evaluation of the physicochemical compatibility of infusion products with medical devices for parenteral use.
Physicochemical characterization of the infusion products through turbidimetry, particulate contamination (visible and sub-visible particles), pH, UV/visible spectroscopy according to European Pharmacopoeia.
Leachables study which can migrate from the container to its content with chromatographic methods : UPLC, GC(FID), GC/MS
Transposition of an HPLC method to an UPLC one for identification of plastic additives. Detection of the leaching of a plastic additive from a PVC infusion bag to its content.
Work with laboratory quality systems (SOPs, GMPs)
GlaxoSmithkline, UK
- Stagiaire Développement analytique
2007 - 2007Evaluation de la performance de colonnes HPLC
Evaluation of the performance of 9 Reverse Phase columns from different manufacturers for a project related to the development of new HPLC columns supply (Separation Sciences Technique Network).
Evaluation of the bed stability of the stationary phase through physical ruggedness study
Identification of 2 columns able to be used as front line columns in a fast method development system used in Chemical Development.
Experience working in a GMP environment, with ICH guidelines.
Novartis
- Stagiaire Développement analytique
RUEIL MALMAISON 2006 - 2006Caractérisation et compréhension de phases amorphes de principe actifs à l'état solide par microcalorimétrie, HyperDSC et diffraction aux rayons X
Solid state characterization of drug substances, applying microcalorimetry, X ray diffraction and thermal analysis for characterization and understanding of amorphous phases of drug substances.
Participation to a method development to determine amorphous content in solid drug substances through Hyper DSC (Differential Scanning Calorimetry) at high heating rates, comparison with the microcalorimetry.
Analysis of different drug substances through microcalorimetry to find the best conditions using different solvents to see amorphous content, for a further method development.
Qualification of a microcalorimeter apparatus: evaluation of the influence of changing parameters in the analysis protocol, and realization of validation experiments.
Stability study of drug substances salts at different temperatures through microcalorimetry.
Solvent screening for amorphous content determination in a drug substance through microcalorimetry.
