Experience

ProductLife Group

• France
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• CMC consultant

  • Dec 2018 - Present

  - Writing of module 3, QOS, IMPD (chemical and biological products)- Writing of CMC variation dossiers (modules 1, 2.3, 3) for Europe and International- Due diligence of MA dossiers (modules 2.3, 2.7, 3 and 5)- Responses to questions of Health Authorities on module 3- Preparation of baseline of module 3- Regulatory compliance activities, gap analysis- Review of analytical validation/transfer protocols and reports- Analysis of on-going stability data- Project management, coordination, contact with clients Show less

• Analytical project manager - Insourcing at Biogaran

  • Apr 2017 - Nov 2018

  - Management of analytical activities of around 100 pharmaceutical products- Due diligence of analytical parts of module 3- Implementation and review of analytical validations and transfers- Analysis of ICH stability data- Writing and review of risk assessment as per ICH Q3D guideline- Regulatory compliance activities (MA dossier vs internal analytical procedures)- Writing of module 3 sections as part of variations- Participation in Quality Risk Management- Interactions with internal (RA, QA, industrial transfer, etc departments) and external (subcontractors, manufacturers, clients, etc) partners Show less



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Analytical data reviewer

  • 2015 - 2016

  - Review of analytical dossiers for drug products, APIs and raw materials - References: European Pharmacopoeia, USP, JP, internal monographs, GMP - Data integrity - Planning of activities - Implementation of KPIs - Review of analytical dossiers for drug products, APIs and raw materials - References: European Pharmacopoeia, USP, JP, internal monographs, GMP - Data integrity - Planning of activities - Implementation of KPIs



Groupe CARSO

• France
• Biotechnology
• 300 - 400 Employee

• Analytical Engineer

  • 2013 - 2015

  - Analyses of pesticides and PAH in food by GC/MS and LC/MS-MS - Development and validation of analytical methods for quantification of pesticides in food by LC-MS/MS - Writing of analytical methods, operational instructions - Management of priorities and deadlines - Participation in staff training and recruitment - Quality aspects: COFRAC, 5S method, LIMS - Analyses of pesticides and PAH in food by GC/MS and LC/MS-MS - Development and validation of analytical methods for quantification of pesticides in food by LC-MS/MS - Writing of analytical methods, operational instructions - Management of priorities and deadlines - Participation in staff training and recruitment - Quality aspects: COFRAC, 5S method, LIMS



Irstea

• France
• Government Administration
• 1 - 100 Employee

• Research officer (apprentice)

  • 2012 - 2013

  Development of innovative sampling systems for monitoring micropollutants in aquatic environments: - Optimization of chemical synthesis of passive samplers (PDMS and modified PDMS) - Characterization of raw materials using DSC, ATG, IR, UV, Raman, NMR techniques - Quantification of pesticides (laboratories experiments and in-situ) using LC-MS/MS technique. Development of innovative sampling systems for monitoring micropollutants in aquatic environments: - Optimization of chemical synthesis of passive samplers (PDMS and modified PDMS) - Characterization of raw materials using DSC, ATG, IR, UV, Raman, NMR techniques - Quantification of pesticides (laboratories experiments and in-situ) using LC-MS/MS technique.



Laboratoire de biologie médicale Altilabo

• Le Puy-en-Velay, Auvergne-Rhône-Alpes, France

• Laboratory Technician

  • Jul 2011 - Aug 2011

  - Receipt of samples (blood, urine) - Protein electrophoresis - Dosage of vitamin D and screening of Lyme disease by chemiluminescence - Receipt of samples (blood, urine) - Protein electrophoresis - Dosage of vitamin D and screening of Lyme disease by chemiluminescence