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Marinella DESERT PUIU

RUEIL MALMAISON

En résumé

Formulation galénique de formes liquides, semi-solides et solides, techniques pharmaceutiques, medical device et cosmétiques (enrobages, pelliculages, fabrication de comprimés, lyophilisation, ...) et solubilisation des principes actifs, cyto-toxiques, développement pré-clinique et clinique, rapports d’études en français et anglais, mise au point de nouvelles formulations pharmaceutiques, transposition d’échelle, réglementation pharmaceutique, dépôt de brevets d’invention.
Réglementation pharmaceutique, pharmacopées européenne, américaine et japonaise, dossiers AMM, veille réglementaire ICH, FDA, EMEA, dossiers IND, eCTD, IMPD.
Développement de nouveaux excipients innovants à base de microgranules pour l’industrie pharmaceutique et cosmétique, techniques d’enrobage et pelliculage en LAF et turbine.
Contrôle analytique de produits pharmaceutiques et cosmétiques selon les monographies des pharmacopées
Techniques d’analyses physico-chimiques : chromatographies diverses, RMN, UV, IR, COT, Karl Fischer, colorimétrie, électrochimie, SM, SAA, , ICP, etc.
Métrologie et systèmes d’assurance qualité : BPL, BPF, GMP, GLP, ISO, HACCP… Qualifications et validation de méthodes d’analyse, d’appareillage scientifique et d’installations industrielles.
Mise en route de laboratoires d’analyses physico-chimique et bactériologique, et de développement galénique principes actifs et excipients.

Mes compétences :
Galénique
R&D
Chimie analytique
Gestion de projet
Industrie pharmaceutique
Validation
QbD
formulation pharmaceutique
Assurance qualité
Contrôle qualité
Réglémentations
Dosage Forms
SAP
Quality Assurance
Pain management
ILIMS
Capsules
functional Project Management
disciplinary team management
development of OTC and medical devices
cultural teams management
Volunteering
Toxicology
Team Management
Risk Management
Responsible for technical visits
Responsible for implementation
Respiratory System
Regulatory Affairs GRA CMC Training
Project Management
Preformulation
Preclinical Development
Oncology
NMR
Microsoft Windows
Microsoft Office
Medical Devices
Lyophilisation
Investigational Medicinal Product Dossier
ICH
Global Pharmaceutical Development
GMP
GC-MS
Excipients
Central Nervous System
CAPA

Entreprises

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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).
  • 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.
  • 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.
  • Ville De Rennes - Technical scientist

    Rennes 1998 - 1999 Waste Water Treatment Plant, France, Responsible for technical visits,
    physicochemical analyses of water and sludge.
  • Ville De Rennes - Technical scientist

    Rennes 1998 - 1999 Waste Water Treatment Plant, France, Responsible for technical visits,
    physicochemical analyses of water and sludge.
  • 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.
  • 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.
  • 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
  • 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

Formations

  • Technology Training Center (Binzen)

    Binzen 2009 - 2009
  • Technology Training Center (Binzen)

    Binzen 2009 - 2009
  • Conservatoire National Des Arts Et Métiers Pôle Sciences et Techniques du vivant

    Paris 2003 - 2009 Chaire de Techniques Pharmaceutiques, Diplôme d’ingénieur en

    Fabrication de médicaments et de cosmétiques (19/20), Stratégies de recherche et développement, Pharmacologie, Réglementations, Pharmacocinétique, Bio-industries, Toxicologie, Métrologie, Plans d’expérience, Management économique et social...
    Mention très bien.
  • Conservatoire National des Arts et Métiers

    Paris 2003 - 2009 Masters Degree

    Manufacture of drugs and cosmetics, Research and Development Strategies, Pharmacology,
    Regulations, Pharmacokinetic, Bio-industries, Toxicology, Metrology, Project Management.
  • Conservatoire National des Arts et Métiers

    Paris 2003 - 2009 Masters Degree

    Manufacture of drugs and cosmetics, Research and Development Strategies, Pharmacology,
    Regulations, Pharmacokinetic, Bio-industries, Toxicology, Metrology, Project Management.
  • Université Rennes 1

    Rennes 1996 - 1997 * CNRS, Laboratoire de synthèses organiques, Université de Rennes 1, France, asymmetrical organic
    synthesis of peptide analogues, determination of structures of new molecules (NMR, IR, MS).
  • Université Rennes 1

    Rennes 1996 - 1997 * CNRS, Laboratoire de synthèses organiques, Université de Rennes 1, France, asymmetrical organic
    synthesis of peptide analogues, determination of structures of new molecules (NMR, IR, MS).
  • University Of Rennes 1

    Rennes 1995 - 1997 Masters Degree
  • University Of Rennes 1

    Rennes 1995 - 1997 Masters Degree
  • Université Rennes 1 (Rennes)

    Rennes 1995 - 1996
  • Institut Polytechnique De Timisoara (Timisoara)

    Timisoara 1987 - 1992 Masters Degree
  • Institut Polytechnique Traian Vuia TCO (Timisoara)

    Timisoara 1987 - 1992 ingénieur chimiste

    Chimie
    Mention très bien.
  • Institut Polytechnique De Timisoara (Timisoara)

    Timisoara 1987 - 1992 Masters Degree

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