Dorle LESCOT SANCHEZ

En résumé

Entreprises

• Neovacs - CMC Study Coordinator

  2017 - maintenant

• ABMI - Project Manager

  Saint Priest 2013 - 2016 Biotechnology (Insuline)
  Missions:
  
  * Project Manager for Utilities department.(Clean Steam, Compressed Air and Water for Injection systems)
  * Validation Engineer in Quality Control department (Air test, Particle counters validation and several
  projects)
  * Validation Engineer and Coordinator in documentation for Wash and Sterilization department in a
  Compliance Projet (CPE, Utensil Washers)

• Bioorganic Research and Services - Quality Assurance Manager

  2009 - 2011 Management of the Quality Assurance Department for the Biotechnology Manufacturing Site in Jerez de la Frontera and the Development and Research Laboratory in Seville.
  Knowledges of the Protein recombination process.
  Design of the Quality Control and Quality Assurance systems, Audit process compliance (ISO 9001, UNE 166002, Regulatory Authorities of Spain and Chile), Critical Control Points in Process, Deviation System, Technical Assistance with laboratory tests, DMAIC methods to find solutions to issues and technical problems.
  Involved in the Regulatory Affairs, principal contact with the Regulatory Agency of drug products in Spain.
  Responsible for the documentation system (SOPs, Registration Formats, Reports)
  

• Pfizer - Tech Transfer Technology

  Paris 2006 - 2008 New product launches “Factive 5 tablets 320 mg: “Americas Award” for the in a record time.
  
  Abilities developed in Project Management
  Budget Forecast, Budget administration, budget reports,
  Deadline schedule monitoring.
  Process Review in coordination with other departments (manufacturing, supply chain, technical services)
  Management of 16 chemists in the laboratory activities, non direct management, two engineers in the quality assurance department and two documentation specialists at the regulatory affairs area.
  

• Pfizer - Team Leader Validation

  Paris 2003 - 2006 Missions:
  
  * Team leader for Analytical Method Validations, analysis of process validation and Stability studies.
  * Writing protocols, and review of Validation and Stability reports
  * Review of master files for the feasibility of the implementation in laboratory. ;
  * Team leader for the New Product Launch Committee. ;
  * Involved in the decision making.
  Award:
  
  * New product launches in record time ``Factive 5 tablets 320 mg: ``Americas Award.

• Grupo Alimenta - Sales Executive

  2003 - 2003

• Schering Plough - Analytical QC

  Hérouville-Saint-Clair 2001 - 2003 Pharmaceutical company
  Missions:
  
  * Perform of the analytical tests of Cleaning process from a protocols, stability analysis, raw material and
  finished product analytical test for release.
  * Proficiency in HPLC (Waters, Agilent) Gas Chromatography (Agilent), Atomic Absorption, dissolution, ie.
  * Review of Master files for key OOS and OOT investigations.
  
  
  
  * Page 2 Ph. +33 641 320 699
  
  Internships in Food Companies

• AMCO International - Stage-Chemist, Quality Control

  2000 - 2001

• Cadbury - Analytical QC

  Paris Cedex 1997 - 1997 beverages, Analytical testing, sampling activities and sensory evaluation.

Formations

• Alliance Française (Paris, Ile De France)

  Ile De France Paris 2011 - 2013 B2
  
  langue Français

• ESERP BUSINESS SCHOOL (Madrid)

  Madrid 2008 - 2009 Master of Business Administration
  
  (Master in Business Administration) ESERP Business School, Madrid Spain.

• ITESM (Tec De Monterrey) (Mexico City)

  Mexico City 2006 - 2007 Administration of pharmaceutical companies
  
  (Diplome) ITESM (Instituto Tecnológico de Estudios Superiores de Monterrey), México City.

• UNAM (Mexico)

  Mexico 1994 - 1999 Bachelor of Science
  
  UNAM (Universidad Nacional Autónoma de México), México City

Réseau

• Anne-Catherine YON

• Arnaud FREREJEAN

• David CHAUVINEAU

• Gaëtan CAPITANI

• Geraud PAPON

• Katell GOACOLOU

• Lotfi BRAHIMI

• Majda ZOUAK

• Martine BELLAGAMBA

• Mathilde DROMARD