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Summary

I am a passionate formulation development manager with over 6+ years experience. My strongest interest is development of innovative drug delivery solutions (e.g. bioavailability enhancement, controlled / sustained release…). Over my career I handled several global projects both for systemic and local (i.e. ocular) delivery, finally leading to clinical and marketed products. I have developed a strong ability in solving technical issues and improving the performance of products. Key skills in product development: - Formulation / Drug Delivery Systems development: oral bioavailability enhancement, ocular delivery - Regulatory: CMC section writing of eCTD, IND, IMPD, NDA, STED... - IP strategy - Project management - CMO management: coordination of manufacturing of technical and clinical batches with external partners - External collaboration management

Experiences

Current Experience

  • Senior CMC Project Manager
    Since January 2016

Past Experience

  • Manager, Formulation Development Évry, France
    September 2013 --- December 2015

  • Deputy Manager, Formulation Development
    September 2012 --- September 2013

  • R&D Study Manager - Formulation Development
    April 2010 --- September 2012

  • Production Pharmacist
    July 2009 --- April 2010

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCommunicativeCreative thinkingCritical thinkingCuriosityFlexibilityInnovative thinkingInterest in knowledgeKindnessOptimismProactivityProblem solvingResult OrientedTrustSociabilitySelf-confidence

Knowledge

LinkedIn Assessment :
Pharmaceutical DevelopmentFormulation developmentDrug DeliveryBioavailability EnhancementLipid Based FormulationsCustomer FocusPharmaceuticsR&DTeam ManagementPharmaceutical ManufacturingScale-upAffaires réglementairesConception de produitFormulationLaboratoireValidationBPF

Skills and Expertise

Self Assessment :
Build the CMC development planPrepare CMC source documents Represent CMC team Coordinate CMC-activitiesChemistry Manufacturing and Controls (CMC) activitiesPeople managementCollaborate with project team Lab scale batchesUse laboratory techniquesAseptic processingbudgeting of R&D activitiesFollow up projectsLead teamsManage multiple projectsManage laboratory proceduresManufacture of non-GMP and GMP batchesmanaging a small teamNon-aseptic processingOral presentationR&DResolves queriesReview experimental plansReview data interpretationSetup of research equipmentSolid state development Work cross-functionally

Education

  • Master in Pharmaceutical Engineering from University of Strasbourg in 2009
  • PharmD in Pharmaceutical Sciences from University of Strasbourg in 2009

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Native
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    CMC Manager CMC Project Manager R&D manager R&D Director Senior Project Manager (PM)
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Paris, France

Others

Driving License
  • Yes