Nicolas LEFEBVRE

En résumé

Entreprises

• Novartis, Centre de biotechnologies - Process coordinator

  2015 - maintenant

• Novartis Pharma AG - QA Specialist, Novartis TechOps Graduate Program

  RUEIL MALMAISON 2014 - 2015

• Novartis, Centre de biotechnologies - Process Expert, Novartis TechOps Graduate Program

  2013 - 2014 Monoclonal antibodies production for commercial and phase III clinical trials purposes
  Main role and responsibilities:
  - Lead process related deviations (risk assessment, root cause investigation, recurrence, impact, corrective and preventive actions)
  - Participate to the expert batch record review
  - Lead continuous improvement initiatives: change controls, IQP (LEAN Six Sigma) project leader
  - Participate to equipment qualification activities
  - Participate to change over activities
  - Contribute to the improvement of USP and DSP teams technical skills
  - People management: 12 production technicians (objectives, evaluations, development plan

• Novartis, Centre de biotechnonlogies - USP Process Specialist, Manufacturing Science & Technology

  2012 - 2013 (Novartis TechOps Graduate Program)
  
  Manufacturing Science & Technology (USP)
  - Project Team Leader of a cross functionnal feasibility study regarding Viral Clearance (cell culture, purification and analytical experiments)
  - Team member of a scale down model development study for a monoclonal antibody production process in perfusion mode.
  - Team Member of process characterization studies
  
  - Project Team Leader of an investment project involving cross functional interaction and project management within BPO Huningue (MS&T, Engineering, Finance, HSE)
  
  - Communication: member of the editorial team for Novartis Huningue internal magazine

• Novartis, Centre de biotechnologies - USP Process Associate, Manufacturing Science & Technology

  2011 - 2012 Manufacturing Science & Technology
  - Scale down of monoclonal antibody production processes (Batch/Fedbatch modes) including validation/characterization studies
  -Technology transfer from development site to full-scale manufacturing site (USP) for monoclonal antibodies production in Phase III and Commercial scale (15 m3)
  -Troubleshooting experiments (USP)
  - Process optimization and feasibility studies (USP)

• NovImmune SA, Geneva (Suisse) - Master's degree trainee (process development)

  2010 - 2011 Project: Optimization of a scalable serum-free transient gene expression process in mammalian cells for monoclonal antibody production
  •Suspension and monolayer cell culture (CHO and HEK293 cells) in serum-free media
  •Production process monitoring (FACS, ELISA and protein A-HPLC)
  •DNA extraction and purification, recombinant proteins expression in E.coli
  •Concentration, antibody purification (proteinA/G), filtration (UF, DF)
  •Analysis of product quality (SDS-PAGE, IEF and SEC-HPLC)
  •Statistical analysis (Graphpad), cost of goods determination, contact with suppliers
  
  Poster presented at ESACT, Vienna 15-19 may 2011
  
  References:
  Yves Poitevin, Head of Antibody Production Unit
  Greg Elson, Head of Manufacturing Department
  
  

• Phycher Bio développement, Cestas (Gironde) - Trainee - Engineer

  2009 - 2009 Setting up of a valuation method for photosensitization: Photo-LLNA
  •Animal experimentation, cell culture
  •Project management, process optimization
  
  

• Laboratoire Matrice Extracellulaire et Pathologie - CHU de Caen (Calvados) - Trainee

  2008 - 2008 Introduction to laboratory techniques (electrophoresis, Western-Blot, cell culture)
  
  

Formations

• Ecole Supérieure De Technologie Des Biomolécules ESTBB

  Bordeaux 2008 - 2011 Biotechnology, specialized in production, purification and characterization of biomolecules
  
  
  
  Référence: Bertrand Garbay, Professeur à l'Université Bordeaux 2 (France) directeur de recherche à l'ENSTBB (Ecole Nationale Supérieure de Technologie des Biomolécules de Bordeaux)
  
  Treasurer of EICOSA (student association of ENSTBB)

• Université Caen Basse Normandie

  Caen 2005 - 2008 3-year university degree in Life Sciences (LMD European system), graduated with honours

• Lycée Jean Francois Millet

  Cherbourg Octeville 2001 - 2005 High school diploma, major in Biology
  
  Preparation for competitive exam for entry into French physical therapy school

Réseau

• David VALLEY

• Marie-Paule ULMER

• Marthe COLOTTE

• Maxime VERGNE

• Myriam SMADJA

• Sandra HELNAN

• Stephane POIGNANT

• Stéphanie MAUNAT

• Valérie GIRARD

• Virginie AHOUANSOU