Guillaume BOIGEY

En résumé

Entreprises

• Sanofi Pasteur - Quality Control Manager

  Lyon 2010 - maintenant Quality Control Manager Virology (Sanofi-Pasteur, Marcy)
  * Management of 5 technical assistants on three vaccine analytical laboratories control (including two team manager and 25 technicians).
  * responsible for the development of quality culture and Regulatory Compliance in laboratories in line with the quality policy Site and pharmaceutical quality standard (cGMP, GMP). ;
  * Pilot quality events and commitments and guarantees their timely manner treatment (deviation, CAPA, OOS and Change Management (CCR)): Principal Investigator ;
  * In charge of a team of investigators (companionship and certification). ;
  * Representing the laboratories outside site and during inspection (ANSM, FDA...) ;
  * Ensure the reliability of results, approval of results in LIMS ;
  * TrackWise deviation and Change control ;
  * Approval and writing of technical documents for the laboratories (SOPs, protocol, report) ;
  * Ensure the maintenance of the validated status of analytical methods ;
  * In charge of the scientific and technical support in the laboratories, resolving technical and analytical issues in laboratories. ;
  * Coordinating technical projects, pilot their planning (internal projects and / or external) ;

• Synbiotics - Technical Director

  2006 - 2010 Technical Director-Synbiotics (CA 20 M EUR , Lyon)-Synbiotics designs, develops, produces and markets veterinary Diagnostics tools (ELISA, lateral flow)
  * In charge of services R & D, industrialization, quality control and production (manufacturing, biochemistry, culture)
  * management of 2 team manager and 20 technicians; supervision of activities, technical expertise ;
  * Member of AFNOR working groups ;
  * Management of R&d projects and quality control activities (product release) ;
  * Ensure compliance with deadlines, costs and regulatory requirements ;
  * Participation in the continuous improvement of quality management system (Pilot) ;

• Diffchamb - R&D project Manager

  2002 - 2005 Sept 2002 - Dec 2005 : R&D project Manager Biotechnologies- Diffchamb (CA 5 M EUR , Lyon)-Diffchamb designs, develops, produces and sells Diagnostics tools for agri-foods
  * R&D project management: bibliographic study, development and validation of methods (ELISA, microbiology), analyze and results presentation ;
  * Writing of technical documents for quality control and production ;
  * Transfer of new product from R&D to production ;
  * Installation and adjustment of ELISA workstation ;
  * training and technical expertise for customers of the agri-food sector ;
  * Customer technical support (Europe) ;

Formations

• ENSBANA

  Dijon 2002 - 2002 Masters Degree
  
  MASTER degree in microbiologie ENSBANA Dijon – mention AB
  

• Université Nantes (Nantes)

  Nantes 2001 - 2001 Major in Immunologie, Université de Nantes –with honours

Réseau

• Anne-Céline CONTAMINE

• Caroline HELENA

• Christel ROCHAS

• Damien SCRIBOT

• Dr. Emeric LEBRETON

• Elodie DIETERLEN

• Inês MARQUES

• Laura PETREMENT

• Muriel COLLUS