Experience

MSD Santé Animale France

• France
• Veterinary
• 100 - 200 Employee

• Process Project Coordinator - MSD Animal Health - Pharmaceutical Technology Solutions

  • Dec 2021 - Present

• Analytical Support Manager

  • Apr 2015 - Dec 2021

  Member of PTS department (Pharmaceutical Technical & Support) in MSD Animal Health Igoville site, I'm responsible for all analytical activities related to analytical transfers and validations. My scope also includes the management of projects related to changes impacting API (Active Pharmaceutical Ingredients) used to manufacture finished product in Igoville -Assessment of the quality of API during change of supplier (dual sourcing / replacement) - Assessment of the impacts of API changes on finished products – Definition of the CPP/CQA of manufacturing process - Coordination of confirmatory / validation batch and analysis - Anticipation of supply risks related to changes – Review of the Regulatory Dossier.Then, I'm a Point of Contact for R&D projects for products in late development stage in prevision of their future commercialization-Assessment of the manufacturing feasibility in industrial environment from manufacturing to packaging including safety aspect – Support to select potential hosting sites for CTM and/or Commercial batches – Product Cost Of Goods calculation – Elaboration of Business Case to apply for hosting product on site.Analytical activitiesImplementation of validated analytical methods in QC Lab to allow the analysis of Raw Materials and Finished Products manufactured on siteContinuous improvement and development of methodsAnalytical support to QC Lab, Support and Conduction of investigation in case of OOS, OOT, complaint, deviationsRegulatory Affairs Support, Answers to regulatory questions following the filing of registration dossiers of finished products manufactured in Igoville. Finally, my activity also includes analytical methods for products in the development phase that can be subsequently manufactured on the site. This activity, in collaboration with the various R & D centers, ensures as much as possible that new methods are being developed to meet needs and technical requirements of the QC lab (friendly QC methods) Show less

• Analytical Project Coordinator

  • Jul 2013 - Mar 2015

  Management of analytical projects ( transfer, validation, development)Support to QC Lab for troubleshootings, investigations.

• Analytical Transfer Coordinator

  • Sep 2009 - Jun 2013

  Coordination of analytical transfer for veterinary productssite to site transferR&D to site transferMethod validation



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analyst - Analytical Development

  • Jul 2005 - Jun 2009

  Analyst within Pharmaceutical Development department in Evreux Site (R&D) - Development / Validation of analytical methods (HPLC UV, Fluo, LC/MS) for asthma products in aerosol - Analysis on aerosol : NGI, DTU, Impurity, TDC Analyst within Pharmaceutical Development department in Evreux Site (R&D) - Development / Validation of analytical methods (HPLC UV, Fluo, LC/MS) for asthma products in aerosol - Analysis on aerosol : NGI, DTU, Impurity, TDC