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Summary

i am a chemical Engineer specializing in Biotechnology, with a focus on Statistics, modeling, optimization and quality. for the past 5 years i have been performing and studying animal Cell cultures (cho, hybridoma) producing biologicals (Antibodies, recombinant Proteins such as the interferon-gamma) for a pharmaceutical industrial context (batch/fedbatch/continuous perfused regimes).

i have finished a post-graduate program in Drug Development, where i have developed skills on ich gcp/glp/GMP guidance, Clinical trials, among others. i am further undergoing an intensive Training at the cefochim Biotechnology center in Clinical research.

i have prior work experience in the industrial sector, dealing with customers, quality certification and process design.

i would like to invest myself professionally in the Pharmaceutical Industry (eg. Quality Assurance) or in the field of Clinical research (eg. Biostatistics, Data Management, pk/pd, Scientific writing, Project Management).

Experiences

Current Experience

  • QA Coordinator

    Rixensart, Belgium
    Since August 2015

    qa release, trending and Compliance and operational qa for 3 Vaccines production units.

    QA Release, Trending and Compliance and Operational QA for 3 vaccines production units.

Past Experience

Personality

Self Assessment :
Analytical thinkingService orientedOptimismCoordinationAttention to detailCollaborationCritical thinkingCreative thinkingEfficiencyFlexibilityInterest in knowledgeInnovative thinkingProactivityOrganizationProblem solvingSociabilityStrategic thinkingTrust

Knowledge

Self Assessment :
It skillsPatient Follow UpPatient Screening and Recruitmentpeople managementPharmaceutical IndustryPharmacodynamicsPharmacokineticsPharmacovigilancePhase IPhase IIPhase IIIPhase IVPatient Reported Outcome Measures (PROMs)New Drug Application (NDA)Multiple dose tolerance studyKnowledge of the drug development processLaTeXMarket accessMarketing approvalMarketing Authorisation Application (MAA)MATLAB (matrix laboratory)Medical DevicesMedical writingMicrosoft ExcelMicrosoft OfficeMonitoring Study ProgressPhases of clinical development (phase I to IV)PowerPointPre-clinical researchScientific methodologyScientific WritingSerious Adverse Event (SAE)SOPStatistical considerations in design and analysisStatisticsStudy outcomes and outcome measuresSupervising CRAsTechnical reportsUnderstand levels of research evidenceInformed Consent DocumentsRegulatory affairsRegistration of the productRate of drug eliminationPreclinical regulations and practicesPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProduct designProgrammingProject ManagementProtocolQuality Assurance (QA)Quality of Life (QoL) outcomesR&DRandomization and blindingWriting Study Procedures and SOPsInterpret clinical trial results BiostatisticsClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial designClinical trialsClinical trial managementData AnalysisClinical Data Management (CDM)Cell CultureCAPA Medical devices Phase I R&D Scientific writingA rising single dose tolerance studyBioavailabilityBioinformaticsBiological Drug DevelopmentBiomarkersBiopharmaceuticalsBiotechnologyData cleaningData entryData ManagementExtent of drug absorptionFDAGCPGood Laboratory Practice (GLP)GMPGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)Good Publication Practice (GPP)HPLCICH GCP guidelinesICH-GCPEthics submission and approval processEnzyme-linked immunosorbent assay (ELISA)EnglishDatabase design and maintenanceDesigning case report formsDrug development processDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDrug substance developmentEfficacy trialsElectronic Data Capture (EDC) ELISAInformed Consent ProcessQAReleaseinspection

Education

  • Ph.D. in Engineering (biotechnology) from Université de Mons in 2015
  • Master in Chemical Engineering from Universidade de Coimbra in 2008
  • 5-Year Degree in Chemical Engineering from Universidade de Coimbra in 2003

Training and Certification

  • CLINET – Expert en Études Cliniques (Cefochim, 23/03/2015–02/06/2015). Functions for which we are trained in: Scientific Writer; Data Manager; CRA/CTA; RA officer; Pharmacovigilance officer; Quality Assurance officer; Biostatistician. in 2015 Training
  • PHARMED: 1-year post-graduate program on Drug Development (ULB, 2014/15): study design, ICH GLP/GCP/GMP guidelines, study monitoring, protocol writing, regulatory affairs, biostatistics, PK/PD, epidemiology, health economics, clinical project management in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Native
    Portuguese
    Native
    French
    Full Proficiency
    Dutch
    Professional Proficiency
    Spanish
    Professional Proficiency
    German
    Elementary Proficiency

Work Preferences

  • Locations I am interested in:
    Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Ottignies-Louvain-la-Neuve, Belgium

Others

Driving License
  • Yes

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