Experience

GALENIX

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project manager

  • Sep 2014 - Present

  Innovation and Development Project Manager Management of the analytical control activity in addition to the activities entrusted in 2014. Management and implementation of analytical method development and validation: - Bibliography (Publications, Eur. Ph, USP, ...) - Redaction of development, validation protocols - Implementation of development, - Redaction of analytical monograph in accordance with developed method - Statistical analysis of analytical validation with AvA Software - Redaction of validation reports Quality control management: - Redaction of pre-stability and stability protocols - Pre-stability, stability studies and routine analysis. - Analysis of developed test product, blend, granules, ... Management of the formulation activity of the Innovation Department (since September 2014) Feasibility study, optimization of existing products, development of new products. Design, production of various innovative galenic formulations (dry and liquid forms). Organization, performance and interpretation of tests, stability and monitoring of manufactured batches.Quality assurance: - Redaction, verification and approbation of quality document (Procedures, forms, ...) - Supporting the OOS (Out Of Specifications), Laboratory incidents (Quality impacting as well as Non-impacting ), Deviations.Management and implementation of maintenance and metrological verification of equipmentsManagement of bibliographic study, competitive Intelligence and patents study Show less

• Formulation technician

  • Jul 2006 - Sep 2014

  Manufacturing of solid, liquid and semi-solid forms:- Preformulation - characterization of raw materials- Development of pharmacotechnical methods (psd, dsc, in-vitro dissolution...)Implementation of various innovative pharmaceutical formulations (liquid and dry forms): organization, implementation and interpretation of tests, pre-stability..Quality control:- Analysis of developed test product, blend, granules, uniformity of dosage unit...- Pre-stability, stability studies and routine analysis.- Forced degradation study (photostability in accordance with ICH guideline, acid, basic, oxiant and thermal degradation testing)- Studies on transdermal passage Franz cells.Management of equipment (maintenance, metrology, QA)Search for new raw materials, new suppliers. Show less



GEMACBIO

• Cenon

• Formulation technician

  • Nov 2003 - Jun 2006



Ethypharm

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Formulation technician

  • Mar 2002 - Sep 2002

  training course Development (trials, analyzes and stability studies) of sphérulites® formulations for an anti-cancer treatment. training course Development (trials, analyzes and stability studies) of sphérulites® formulations for an anti-cancer treatment.