Experience

MSD Santé Animale France

• France
• Veterinary
• 100 - 200 Employee

• Pharmaceutical Analytical Technical Support Regional Lead

  • Jun 2021 - Present

  Management of analytical transfers for new products and new excipients. Analytical method troubleshooting and QC lab technical support Analytical method improvements Management of analytical transfers for new products and new excipients. Analytical method troubleshooting and QC lab technical support Analytical method improvements



Valdepharm

• France
• Chemical Manufacturing
• 200 - 300 Employee

• Analytical Development & Support Manager

  • May 2015 - Jun 2021

  Management of a team of 8 to 12 analysts and supervisors in charge of Analytical Development & Support for the site. Management of all analytical topics for new products introduction, from Raw Materials to Finished Products (Custom synthesis APIs, Generic APIs & Custom Drug Products), including intermediates. -Member of the Core Project team for all new products from start to finish (15+ products introduced on site to date) -Direct customer contact for all analytical topics -Control… Show more Management of a team of 8 to 12 analysts and supervisors in charge of Analytical Development & Support for the site. Management of all analytical topics for new products introduction, from Raw Materials to Finished Products (Custom synthesis APIs, Generic APIs & Custom Drug Products), including intermediates. -Member of the Core Project team for all new products from start to finish (15+ products introduced on site to date) -Direct customer contact for all analytical topics -Control Strategy definition for the whole process, including specification definition in close relationship with R&D, Regulatory, Project and QA teams. -Analytical methods development, validation, transfer -Analytical support for R&D & Process Teams -Various product studies (ICH Q1A stress studies, ICH Q1B photostability, ICH Q3D screening, ICH M7 testing and spike experiments in coordination with R&D...) Site Analytical Expert -Regulatory Answer for all questions related to analytical topics -QC support for method troubleshooting and optimisation -Analytical Support for process troubleshooting New Analytical Technologies integration in QC -Integration of ICP-MS, LC-MS, Ion Chromatography, Corona CAD detection, Malvern Mastersizer MS3000 -Development of UPLC methods -Qualification of Empower 3 CDS software and Client-Server architecture integration.

• Analytical Development & Support Coordinator

  • Nov 2013 - Apr 2015

  FDA & EU Approved site for manufacturing APIs and Drug Products Direct Management of a team of 6 to 8 analysts in charge of method implementation (Development, Transfer, Validation) and Analytical Support. Analytical Methods Troubleshooting for QC Analytical Support to R&D, Industrial Transfer, QA and Production teams.



MSD Santé Animale France

• France
• Veterinary
• 100 - 200 Employee

• QC Laboratory Supervisor

  • May 2012 - Nov 2013

  FDA & ANSES-Approved site Direct Management of 5 to 15 QC Analysts in close relationship with production and QA teams in order to fulfill all customer's needs. Lean Laboratory Improvements -MSD Yellow Belt Training -Planning optimization (visual planning development, communication with other services improvements) -Workflow optimization for High-Runner products : Spaghetti diagrams, tasks scheduling, pattern wheel planning... Analytical methods optimization work Deviation… Show more FDA & ANSES-Approved site Direct Management of 5 to 15 QC Analysts in close relationship with production and QA teams in order to fulfill all customer's needs. Lean Laboratory Improvements -MSD Yellow Belt Training -Planning optimization (visual planning development, communication with other services improvements) -Workflow optimization for High-Runner products : Spaghetti diagrams, tasks scheduling, pattern wheel planning... Analytical methods optimization work Deviation Management Budget & Ressources planning and optimization Show less FDA & ANSES-Approved site Direct Management of 5 to 15 QC Analysts in close relationship with production and QA teams in order to fulfill all customer's needs. Lean Laboratory Improvements -MSD Yellow Belt Training -Planning optimization (visual planning development, communication with other services improvements) -Workflow optimization for High-Runner products : Spaghetti diagrams, tasks scheduling, pattern wheel planning... Analytical methods optimization work Deviation… Show more FDA & ANSES-Approved site Direct Management of 5 to 15 QC Analysts in close relationship with production and QA teams in order to fulfill all customer's needs. Lean Laboratory Improvements -MSD Yellow Belt Training -Planning optimization (visual planning development, communication with other services improvements) -Workflow optimization for High-Runner products : Spaghetti diagrams, tasks scheduling, pattern wheel planning... Analytical methods optimization work Deviation Management Budget & Ressources planning and optimization Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Development Coordinator

  • Sep 2011 - Mar 2012

  Development, Transfert, Validation of GC / HPLC / UPLC Methods for Impurities and Additives in Vaccines. Work with lab technicians and small projects management including documentation and change control. Continuous Improvement work in the laboratory : -Work on Reagent management (Stocks, expiry dates management) -Work on documentation improvement (Worksheets, Analytical Methods) -HPLC System suitability alignement between all methods in laboratory and associated SOP… Show more Development, Transfert, Validation of GC / HPLC / UPLC Methods for Impurities and Additives in Vaccines. Work with lab technicians and small projects management including documentation and change control. Continuous Improvement work in the laboratory : -Work on Reagent management (Stocks, expiry dates management) -Work on documentation improvement (Worksheets, Analytical Methods) -HPLC System suitability alignement between all methods in laboratory and associated SOP writing. Technical Support (Methods and/or equipment troubleshooting) for the whole laboratory and method continuous improvement work. Show less Development, Transfert, Validation of GC / HPLC / UPLC Methods for Impurities and Additives in Vaccines. Work with lab technicians and small projects management including documentation and change control. Continuous Improvement work in the laboratory : -Work on Reagent management (Stocks, expiry dates management) -Work on documentation improvement (Worksheets, Analytical Methods) -HPLC System suitability alignement between all methods in laboratory and associated SOP… Show more Development, Transfert, Validation of GC / HPLC / UPLC Methods for Impurities and Additives in Vaccines. Work with lab technicians and small projects management including documentation and change control. Continuous Improvement work in the laboratory : -Work on Reagent management (Stocks, expiry dates management) -Work on documentation improvement (Worksheets, Analytical Methods) -HPLC System suitability alignement between all methods in laboratory and associated SOP writing. Technical Support (Methods and/or equipment troubleshooting) for the whole laboratory and method continuous improvement work. Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Development Coordinator

  • Mar 2010 - Dec 2010

  Development, Transfert and Optimisation of HPLC/UPLC Methods for Organic Impurities control in Vaccines New analytical Equipement (HPLC) Qualification Development, Transfert and Optimisation of HPLC/UPLC Methods for Organic Impurities control in Vaccines New analytical Equipement (HPLC) Qualification



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Internship

  • Feb 2009 - Aug 2009

  21CFR part 11 compliance update for Chromatography Software : -Workflow definition -Automated report sheets creation -SOP update People training on chromatography software (15+ people trained) 21CFR part 11 compliance update for Chromatography Software : -Workflow definition -Automated report sheets creation -SOP update People training on chromatography software (15+ people trained)