Julie DURIEUX

En résumé

Entreprises

• Orphan Europe - Pharmaceutical Development Project Manager

  2012 - maintenant - Writing and update of Module 3 of CTD files
  - Writing of Variations in compliance with regulatory procedures
  - Collaboration for writing of answers to Partners and Authorities questions on CMC part
  - Work in collaboration with internal and external interlocutors
  - Knowledge of European and International Law

• Stallergenes - Regulatory Affairs Officer

  ANTONY 2012 - 2012 - Writing and submission Module 3 for Renewal Dossier of Existing Products
  - Participation in the elaboration of the regulatory strategy (Specifications and Development of analytical method)
  - Participation and interlocutor in the inter-department working groups (Analytical Development), to answer regulatory requests.
  - Knowledge of European and International Law

• Stallergenes - Analytical Project Officer

  ANTONY 2011 - 2012 - Organization and activity monitoring of various projects related to Analytical Development and in collaboration with different departments.
  - Participation in reading and editing of regulatory documents.
  - Active participation in meetings and inter-department working groups for the set up of regulatory engagement
  - Participation in the development of pharmaceutical product specifications and validation of methods
  - Worked in a GxP environment, GMP experiences

• Stallergenes - Coordinator for stability studies

  ANTONY 2010 - 2011 - Results analysis for stability studies of finished products and raw materials
  - Final study report in French and English
  - Participation in the establishment of stability study balance sheet in collaboration with the Regulatory Affairs department

• SANOFI PASTEUR - Research Associate - VIE contract (Volontariat International en Entreprise)

  Lyon 2008 - 2009 - Performed the development of Mass Spectrometry assays to analyze protein and poly-glycans, and study the size of polysaccharide followed by MALDI-TOF and HPAEC-PAD/ LC-MS (Report and oral presentation in English)
  ­- Involved in separation and quantification of antigens and minor ingredient by HPLC
  ­- Performed a stability study on one of the vaccines in correlation with another platform.
  ­- Analyzed of proteomic application by LC/MS
  ­- Synthesized and derivatized of sugar molecules
  ­- Separated molecules by theirs different hydrophobicity by HPAEC-PAD solid phase separation
  ­- Performed wet chemistry analysis for different sugar content measurement
  ­- Presented results in weekly platform meetings and participated in video conferences
  ­- Worked under Standard Operating Procedures (SOPs) in a GxP environment
  ­- Properly maintained my R&D laboratory notebook

• Novocol Pharmaceutical of Canada, Inc - Chemistry Technician (Internship)

  2007 - 2007 ­- Used of analysis apparatus (autotitrator, IR and UV spectroscopy, pH…) to verify the suitability of injectable anaesthetics,
  ­- Analyzed following the specific procedures and used of the database.

• Centre de Recherche et de Restauration des Musées de France - C2RMF Musee du Louvre - Laboratory Technician (Internship)

  2006 - 2006 ­- Prepared samples by chemical pretreating and combustion for Carbon 14 Dating
  ­- Used specific database

Formations

• Chimie Physique Electronique De Lyon

  Lyon 2007 - 2008 Diplôme d'Ingénieur Chimiste Spécialité 'Sciences du Vivant et Santé'
  
  Chimie Analytique/Biochimie

• Ecole Nationale Supérieure De Chimie De Clermont-Ferrand (Clermont Ferrand)

  Clermont Ferrand 2005 - 2007 Diplôme d'Ingénieur Chimiste Spécialité 'Sciences du Vivant et Santé'

• ENCP

  Paris 2003 - 2005 Chimie , Physique, Mathématique

• Lycée Hélène Boucher

  Paris 2000 - 2003 Sciences

Réseau

• Agathe SALLUSTRAU

• Aissa DJOBOUNGUE

• Axelle HUET

• Aziza DIB

• Corinne DELAPIERRE

• Guilaine ARDUIN ROULLIER

• Jean-Philippe LETELLIER

• Nicole COHEN

• Stéphanie SEMET