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Novartis Consumer Health S.A.
- Senior Pharmaceutical Development Scientist II
RUEIL MALMAISON
2012 - maintenant
Supervise development, scale-up and scale-down, transfert and validation for new OTC products and medical device.
Plan and conduct experiments of a high degree of complexity, covering formulation development, prestability, registration stability and clinical batch suply.
Core team member for R&D projects, leading GPD activities in multi-functional teams.
Writting of CMC section for the soumission dossier for Health Authorities.
Consolidate and analyze data from various sources, draw conclusions and recommend scientific solution, prepare technical reports.
Financial forecast and budget follow up for R&D projects.
Due diligence.
Quality by Design.
Scientific presentations.
GMP compliance.
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NOVARTIS CONSUMER HEALTH
- Scientist
2012 - 2015
Global Pharmaceutical Development, Senior Pharmaceutical II, Supervise the formulation development of OTC and medical devices, liquid, semi-solid and
solid dosage forms, suppliers relationships and internal partnership (Regulatory, Clinical, Toxicology,
Packaging, MS&T, QA), project manager for complex projects with Swiss, US and Indian facilities, writing
of CMC part of regulatory dossiers, answers to HA's, solutions for complex projects (from early stage to
registration), scale-up/scale-down, transfer of technology from R&D to manufacturing and from one site
to another site, preclinical and clinical batches manufacturing, due diligence for third party, complex
team management, core team member for R&D project, leading activities in multi-functional teams,
trouble shooting and support to manufacturing, outsourcing, implementation of QbD methodologies,
technical protocols, reports and procedures writing and reviewing, scientific literature search, patent
studies, proposal of new innovative formulations.
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NOVARTIS CONSUMER HEALTH
- Scientist
2012 - 2015
Global Pharmaceutical Development, Senior Pharmaceutical II, Supervise the formulation development of OTC and medical devices, liquid, semi-solid and
solid dosage forms, suppliers relationships and internal partnership (Regulatory, Clinical, Toxicology,
Packaging, MS&T, QA), project manager for complex projects with Swiss, US and Indian facilities, writing
of CMC part of regulatory dossiers, answers to HA's, solutions for complex projects (from early stage to
registration), scale-up/scale-down, transfer of technology from R&D to manufacturing and from one site
to another site, preclinical and clinical batches manufacturing, due diligence for third party, complex
team management, core team member for R&D project, leading activities in multi-functional teams,
trouble shooting and support to manufacturing, outsourcing, implementation of QbD methodologies,
technical protocols, reports and procedures writing and reviewing, scientific literature search, patent
studies, proposal of new innovative formulations.
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HRA PHARMA
- Officer
2011 - 2012
Exchanges with the HA's on CMC part of the MAA dossiers (oral dosage forms), provide answers to
technical questions, writing and up to date of module 3 of and IMPD, filing of a type II variation in Europe,
up to date of IND and NDA, management of new development projects (pharmaceutical and analytical),
development strategies contributor, technical investigations for OOT/OOS, outsourcing follow-up for
analytical and process validation, collaboration with internal and external partners (manufacturing and
analytical), patentability for new formulations, devices and proposal of innovative products.
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HRA PHARMA
- Officer
2011 - 2012
Exchanges with the HA's on CMC part of the MAA dossiers (oral dosage forms), provide answers to
technical questions, writing and up to date of module 3 of and IMPD, filing of a type II variation in Europe,
up to date of IND and NDA, management of new development projects (pharmaceutical and analytical),
development strategies contributor, technical investigations for OOT/OOS, outsourcing follow-up for
analytical and process validation, collaboration with internal and external partners (manufacturing and
analytical), patentability for new formulations, devices and proposal of innovative products.
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HRA PHARMA
- Chargée des affaires technico-réglementaire
2011 - 2012
Réponses aux autorités internationales sur les dossiers d’AMM sur la partie CMC, mise à jours et rédaction de variations pour les dossiers d’AMM (module 3, pour l’international), d’IMPD, d’AND, participation à la l’élaboration de la stratégie réglementaire, rédaction et suivi de dossiers techniques, projets de développement galénique et analytique, suivi des sous-traitants, investigations techniques et qualité pour OOS et OOT.
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NPPHARM COLORCON
- Research and Development Manager
2007 - 2011
* NPPHARM COLORCON, (ETHYPHARM subsidiary), France, Research and Development Manager,
Cross functional projects management, implementation of R&D department, manufacturing process
improvement, research and development of new innovative pharmaceutical excipients, multiparticulates
forms development, scientific and regulatory survey, relationships with academics and R&D centres,
academic conferences, management of R&D projects, scale up and scale down, development of
innovative excipients for customers, patent filling of invention WO/2010/112762, external scientific
communications (PharmScifair, academic schools).
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NPPHARM COLORCON
- Research and Development Manager
2007 - 2011
* NPPHARM COLORCON, (ETHYPHARM subsidiary), France, Research and Development Manager,
Cross functional projects management, implementation of R&D department, manufacturing process
improvement, research and development of new innovative pharmaceutical excipients, multiparticulates
forms development, scientific and regulatory survey, relationships with academics and R&D centres,
academic conferences, management of R&D projects, scale up and scale down, development of
innovative excipients for customers, patent filling of invention WO/2010/112762, external scientific
communications (PharmScifair, academic schools).
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COLORCON NPPHARM (ex filiale ETHYPHARM)
- Responsable Recherche et Développement Galénique
2007 - 2011
Mise en route du laboratoire de développement galénique, étude du process de fabrication et améliorations, recherche et développement de nouveaux excipients pharmaceutiques et cosmétiques, transferts d’échelle (scale-up et scale-down), planification et pilotage de plusieurs projets, veille technologique et réglementaire, collaborations avec des Universités, centres de R&D et sous-traitants, conférences au CNAM, communication PharmSciFair 2009, dépôt de brevet d’invention.
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CEPHALON France
- Pharmaceutical scientist
2004 - 2007
dosage forms, formulation for PK/PD and preclinical studies with new poorly soluble APIs (oncology,
SNC, pain), pre formulation, innovative formulations, optimization of formulas, characterization of
formulations and API (cytotoxic), APIs solubilities, batches for clinical trials and transfer of formulation
process from France to USA, manufacturing of clinical batches at a US contract manufacturing
organization, writing and update of quality documents, writing of technical reports and procedures,
scientific literature search and patent studies.
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CEPHALON France
- Pharmaceutical scientist
2004 - 2007
dosage forms, formulation for PK/PD and preclinical studies with new poorly soluble APIs (oncology,
SNC, pain), pre formulation, innovative formulations, optimization of formulas, characterization of
formulations and API (cytotoxic), APIs solubilities, batches for clinical trials and transfer of formulation
process from France to USA, manufacturing of clinical batches at a US contract manufacturing
organization, writing and update of quality documents, writing of technical reports and procedures,
scientific literature search and patent studies.
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CEPHALON, Service Formulation Développement
- Techniciènne galéniste
2004 - 2007
Formulation de formes injectables et orales pour les études pré-cliniques et cliniques, optimisation de formules, caractérisation de formulations et de principes actifs (cyto-toxiques), solubilisation de Principes Actifs failblement solubles, transfert de formulation et lots de faisabilité pour les essais cliniques (aux Etats Unis), collaboration avec sous-traitants pour la fabrication des lots cliniques, rédaction et mise à jour des documents qualité, rédaction de rapports en français et en anglais.
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Drug and Finished Products
- Chemist
2002 - 2004
* SGS, Laboratoire Simon France, Analytical control of pharmaceutical and cosmetics products (Drug ), coordination of physicochemical analyses of water according
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Drug and Finished Products
- Chemist
2002 - 2004
* SGS, Laboratoire Simon France, Analytical control of pharmaceutical and cosmetics products (Drug ), coordination of physicochemical analyses of water according
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SGS, Laboratoire Simon France
- Techniciènne chimiste
2002 - 2004
Contrôle analytique de produits pharmaceutiques et cosmétiques, coordination d’analyses physico-chimiques des eaux selon les pharmacopées européenne, américaine et japonaise ; prélèvements d’environnement et d’eaux purifiées (pour Sanofi Aventis, Schering, l’Oréal).
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USP
- Quality Assurance Manager Assistant
2000 - 2002
to the Ph.Eur, JP, USP. Close collaboration with Sanofi Aventis.
France, Quality Assurance Manager Assistant, starting up of a
microbiological analysis laboratory, traceability of raw materials and manufactured products, commercial
management, commercial and administrative follow-up, orders, invoices and stock follow up.
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USP
- Quality Assurance Manager Assistant
2000 - 2002
to the Ph.Eur, JP, USP. Close collaboration with Sanofi Aventis.
France, Quality Assurance Manager Assistant, starting up of a
microbiological analysis laboratory, traceability of raw materials and manufactured products, commercial
management, commercial and administrative follow-up, orders, invoices and stock follow up.
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Ville De Rennes
- Technical scientist
Rennes
1998 - 1999
Waste Water Treatment Plant, France, Responsible for technical visits,
physicochemical analyses of water and sludge.
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Ville De Rennes
- Technical scientist
Rennes
1998 - 1999
Waste Water Treatment Plant, France, Responsible for technical visits,
physicochemical analyses of water and sludge.
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VIVENDI
- Chemist
Paris Cedex 08
1997 - 1998
Qualification of analysis methods for metals by atomic absorption
spectrometry, Quality Assurance System, Dosage of various pollutants in drinking water.
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VIVENDI
- Chemist
Paris Cedex 08
1997 - 1998
Qualification of analysis methods for metals by atomic absorption
spectrometry, Quality Assurance System, Dosage of various pollutants in drinking water.
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Inra
- Chemist
Paris
1996 - 1996
* INRA, Laboratoire d'Ecologie Aquatique, Rennes, Development of a new method of dosage
pesticides in water (GC/MS), Starting up of the method and implementation of a physicochemical
analysis laboratory of pesticides and other pollutant.
MAJOR SCIENTIFIC ACCOUNTABILITIES
* Project management: management of complex, cross-functional and multi-sites projects, multi-cultural teams
management, global virtual team management, team members coaching, outsourcing and suppliers management
experience with matrix organizations, PMBOK training and experience.
* Process engineering: manufacturing of pharmaceutical, medical devices and cosmetics, coating in turbine and
fluidized bed, layering, tableting, multiparticulates, capsules, freeze-drying, scale-up and scale-down, technology
transfer from R&D to manufacturing plant and from a site to another site, PAT, QbD, troubleshooting, risk analyse.
* Formulation: pre-formulation and formulation of liquid (oral, nasal, parenteral), solid (tablets, capsules, sachets,
lyoc, multiparticulates) and semi-solid (creams, gels) dosage forms, development of new and innovative
pharmaceutical formulations, poorly soluble compounds solubilization, planning and management of experiments
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Inra
- Chemist
Paris
1996 - 1996
* INRA, Laboratoire d'Ecologie Aquatique, Rennes, Development of a new method of dosage
pesticides in water (GC/MS), Starting up of the method and implementation of a physicochemical
analysis laboratory of pesticides and other pollutant.
MAJOR SCIENTIFIC ACCOUNTABILITIES
* Project management: management of complex, cross-functional and multi-sites projects, multi-cultural teams
management, global virtual team management, team members coaching, outsourcing and suppliers management
experience with matrix organizations, PMBOK training and experience.
* Process engineering: manufacturing of pharmaceutical, medical devices and cosmetics, coating in turbine and
fluidized bed, layering, tableting, multiparticulates, capsules, freeze-drying, scale-up and scale-down, technology
transfer from R&D to manufacturing plant and from a site to another site, PAT, QbD, troubleshooting, risk analyse.
* Formulation: pre-formulation and formulation of liquid (oral, nasal, parenteral), solid (tablets, capsules, sachets,
lyoc, multiparticulates) and semi-solid (creams, gels) dosage forms, development of new and innovative
pharmaceutical formulations, poorly soluble compounds solubilization, planning and management of experiments
