Yann DELEZE

En résumé

Entreprises

• Baxter Healthcare - Sr Project Manager Contract Manufacturing

  2014 - maintenant * Description
  Manage CMO projects for large bulk molecules from the partner selection (due diligence) to clinical and commercial manufacturing (virtual plant manager)
  * Accomplishments
  Successful tech transfer and scale-up feasibility of a Biotech Bulk Process to a US CMO in order to evaluate tech transfer activities and develop commercial partnership. Feasibility phase required multicountries management of 10 peoples (US, Austria, Switzerland). Budget of $22M for feasibility phase and approximately $200M for implementation.
  
  Define Business Case and obtain budget to start Tech transfer of two Bulk processes to a European CMO in order to supply material for clinicals phase III.

• Baxter Bioscience - Project manager

  2005 - 2014 * Description :
  Efficient strategic projects management (schedule, cost, quality) for Manufacturing Capacity increase; from projects definitions to implementation
  * Accomplishments
  New Manufacturing suite for new product implementation requesting process, utilities and offices buildings. Responsibilities include Process Tech transfer, Cost and Schedule management. Approved budget $129M and 110 FTEs
  
  Doubling the Filling capacities by adding new freeze dryers and extending the existing aseptic areas. Additional buildings and utilities equipment were part of the project scope. Total budget $30M and 30 FTEs team.
  
  Divisional Award obtained in High Value Project Category and Project Management by increasing bulk capacity of 25% ($10M budget)
  
  Elimination of deviation related to on-line conductivimeters calibration by applying DMAIC methodology.
  
  Simulations performed with SuperProDesigner and ScheduleProDesigner to identify several strategic projects of capacity increase.

• Baxter Bioscience - Microbiology and Environmental Control QC Supervisor

  2001 - 2005 * Description
  Microbiology QC labs management (10 peoples)
  
  Creation and management of an Environmental Monitoring team (6 peoples)
  
  Responsible for QC labs samples management (2 peoples)
  
  
  
  
  * Accomplishments
  Establishment, in collaboration with manufacturing department, of the Filling Aseptic Areas Environmental Monitoring and Fluids Monitoring Program ((purified water and process gases)
  
  DMAIC Project : consumables cost reduction for all QC labs (100'000 CHF/year)
  
  Active and successful participation to internal and regulatory authorities inspections (FDA, Canada, Swissmedics,...)
  
  Team member of ISO 9001 certification obtained for Baxter Bioscience Neuchâtel Facility

• Baxter International - Microbiology QC Supervisor

  Maurepas 2001 - 2005 Microbiology QC labs management (10 peoples)
  
  Creation and management of an Environmental Monitoring team (6 peoples)
  
  Responsible for QC labs samples management (2 peoples)
  

• Baxter Bioscience - Bioren SA - SPEN - QC Chemistry and Microbiology Technician

  1996 - 2001 * Description
  Chemical and microbiological Quality Control Testings in Pharmaceutical Companies
  
  * Accomplishments
  HPLC and Fluorimetry methods validation for Proteins Concentration
  
  Raw material qualifications according to Pharmacopoeia
  
  Independent Microbiology lab management, development of new galenic forms for perfusion and vials
  
  Management of Stability Program
  
  HPLC and colorimetric testings of soil, air and sludge sewage samples
  
  TOC methods development

• Orgamol SA - Chemistry Lab Technician

  1992 - 1995 * Description
  Lab synthesis development on small molecules for large scale implementation
  
  * Accomplishments
  Optimization of chemistry synthesis
  
  Manufacturing support at lab scale (improvement of existing processes and development of purification methods for non-conform batches)

Formations

Pas de formation renseignée

Réseau

• Brice GALEA

• Catherine SCHUTZ

• Isabelle GAGNON

• Laurence ROBERT

• Mickaël NEVEU

• Muriel DETHIER

• Ronan VILLIEN

• Sannaa EL MAAROUFI ELIDRISSI

• Stéphane COLOMBO