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Summary

i choose to study fields of Pharmacy because of great impulse for helping others with their real Health problems. systematic approach, patience, creativity and wish to know new things about useful science determine the position in analytic Chemistry.

Experiences

Current Experience

  • CMC Development lead- analytical

    Mechelen, Belgium
    Since January 2018

  • Senior research scientist

    Serbia
    Since December 2007

    key achievements:
    • more than 15 projects of new drug products have been realized and registered with results higher than expected on a different markets. projects costs were reduced through decreasing number of sample Analysis while quality of output data was not compromised.
    • leading a team of scientists, enhanced Communication with non-Pharmacists pmo team members and reduced costs of project because this activity did not have to be outsourced.
    • managing activities of team members (with different scientific backgrounds) enabled implementation of new approaches, encouraged innovative thinking, which led to effective registering of a new drug products.
    • earned role of qa edqms (electronic Document Management system) key user with demonstrated skills after 6 years as a Member of qa teams.
    Lab-manager position – lead a team of 20 employees, monitoring of purchases of equipment, reagents, consumables and other Laboratory equipment with key role in budget Planning and preparation of project cost estimates.
    Analysis of Pharmaceutical api and Pharmaceutical dosage forms using HPLC Testing, gc Testing, dissolution Testing, Spectroscopy, particle size distribution, potentiometric Titration.

    in charge of:
    Analysis of Pharmaceutical api and Pharmaceutical dosage forms (drug products) using different techniques snd softwares
    • operation, maintenance and Troubleshooting of different Analytical Chemistry techniques(HPLC, gc, ir, psd,...)
    • knowledge of SAP operating system and edqms system
    • lean and Six Sigma basics -yellow belt certified (implemented kaizen philosophy)
    • using of route cause Analysis, process mapping
    • development and delivery of continuous improvement
    • writing and executing method Validation protocols and reports
    • write sops and other Documentation
    • regulatory submissions activities – maintenance, coordination and preparation of cmc document packages for regulatory submissions (paper and eCTD); including maa (global), post approval supplements (nda), variations (ctas, inds, impds), amendments, ind/nda, anda annual reports, drug master files)
    • writing and reviewing Validation, clinical/bio-analytical,stability and transfer protocols and reports for regulatory submission soundness (be - studies of bioequivalence and other Clinical trials)
    • evaluated and reviewing current package (Pharmacokinetics, Pharmacodynamics and other Statistical results) for different drug products to ensure that methods are appropriately validated per ICH guidelines, FDA regulations and eu regulations, transferable to other global markets
    • managing analytical activities at different company production Manufacturing sites
    • activities as a part of different transfer teams in corporation (part of numerous transfer teams with cmc/qc/qa/production team members)

    Key achievements:
    • More than 15 projects of new drug products have been realized and registered with results higher than expected on a different markets. Projects costs were reduced through decreasing number of sample analysis while quality of output data was not compromised.
    • Leading a team of scientists, enhanced communication with non-pharmacists PMO team members and reduced costs of project because this activity did not have to be outsourced.
    • Managing activities of team members (with different scientific backgrounds) enabled implementation of new approaches, encouraged innovative thinking, which led to effective registering of a new drug products.
    • Earned role of QA EDQMS (Electronic document management system) Key user with demonstrated skills after 6 years as a member of QA teams.
    • Lab-manager position – lead a team of 20 employees, monitoring of purchases of equipment, reagents, consumables and other laboratory equipment with key role in budget planning and preparation of project cost estimates.
    Analysis of pharmaceutical API and pharmaceutical dosage forms using HPLC testing, GC testing, dissolution testing, spectroscopy, particle size distribution, potentiometric titration.

    In charge of:
    • Analysis of pharmaceutical API and pharmaceutical dosage forms (drug products) using different techniques snd softwares
    • Operation, maintenance and troubleshooting of different analytical chemistry techniques(HPLC, GC, IR, PSD,...)
    • Knowledge of SAP operating system and EDQMS system
    • Lean and Six Sigma basics -Yellow belt Certified (implemented Kaizen philosophy)
    • Using of route cause analysis, process mapping
    • Development and delivery of continuous improvement
    • Writing and executing method validation protocols and reports
    • Write SOPs and other documentation
    • Regulatory submissions activities – maintenance, coordination and preparation of CMC document packages for regulatory submissions (paper and eCTD); including MAA (global), post approval supplements (NDA), variations (CTAs, INDs, IMPDs), amendments, IND/NDA, ANDA Annual Reports, Drug Master Files)
    • Writing and reviewing validation, clinical/bio-analytical,stability and transfer protocols and reports for regulatory submission soundness (BE - studies of bioequivalence and other clinical trials)
    • Evaluated and reviewing current package (pharmacokinetics, pharmacodynamics and other statistical results) for different drug products to ensure that methods are appropriately validated per ICH guidelines, FDA regulations and EU Regulations, transferable to other Global markets
    • Managing analytical activities at different company production manufacturing sites
    • Activities as a part of different transfer teams in corporation (part of numerous transfer teams with CMC/QC/QA/Production team members)

Past Experience

  • Pharmacist

    September 2006 --- December 2007
    i worked at the Pharmacy for 6 month, as a Sales assistant and drug-maker. also worked at the Laboratory-my job had connection with Quality Control of drugs and technology of making preparations. also worked for two months in Hospital Pharmacy so i had a chance to meet with this role of Pharmacist in national Health system.

Personality

Self Assessment :
Analytical thinkingAssertivenessAttention to detailApproachabilityCommunicativeCreative thinkingCritical thinkingCuriosityFlexibilityIndependenceIndividualityInnovative thinkingKindnessOptimismOrganizationProblem solvingResponsibilitySelf-disciplineSociabilityStrategic thinkingTrustWillingness to compromise

Knowledge

Self Assessment :
Biochemistry Lab scale batches Medical devices Negotiation R&D Scientific writingAnalytical ChemistryAnalytical techniquesAssay developmentBioavailabilityChromatographyChemistryCMC Contract negotiationCross-functional team leadershipDrug development processDrug InteractionDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceEMAFDAGalenicsGood Laboratory Practice (GLP)GMPGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)HPLCICH GCP guidelinesIn VitroIn VivoINDLaboratoryLaboratory ManagementLaboratory ResearchLaboratory study designLaboratory testingMicroscopyNegotiationOphthalmologyPatentsPharmaceutical IndustryPowerPointProblem-solving methods and troubleshootingProcess improvement
LinkedIn Assessment :
HPLCPharmaceuticsChemistrygas chromatographySOPValidationTechnology transferLaboratoryRegulatory submissionsSpectroscopyFormulationQuality Control (QC)V&VGMPTitrationTechnical OperationsDigital StrategyAnalytical SkillsProject PlanningPharmaceutical IndustryRegulatory affairsSOP

Skills and Expertise

Self Assessment :
Assure medical quality Create SOPs Guide students Interpret data Lab scale batches Technology research Write papersAdjust methodsAdjust processes and methodsAPI synthesis route developmentAttend seminarsbudgeting of R&D activitiesCollect dataCommunicate with investigatorCommunicate with sponsor

Education

  • Master's Degree in Pharmaceutical Science from University of Pharmacy in 2006
  • in natural science - mathematics from Vera Blagojevic" High School in 2000

Training and Certification

  • • Hemofarm A.D, Vrsac, 2013-2015, Talent Development Program - monthly in-house training on different topics in interpersonal communications, team effectiveness, personal development in 2015 Training
  • • Mokra Gora School of management, Mokra Gora Serbia, 2013, Basic Management Program – 9 days training course on management basics in 2013 Training
  • • University of Pharmacy, Belgrade, 2007, Drugs in control of pain in 2007 Training
  • • Cluster Phenomenax Belgrade, 2013, Course of S.Chromidas - Integration of chromatographic data and The selection of the "right" column in 2013 Certification
  • • Agilent Technologies, Belgrade, 2008, Reversed Phase HPLC Method Development, Optimizing Productivity- Balanced Fast LC in 2010 Certification
  • • Agilent Technologies, Belgrade, 2010, Tips and Tricks Seminary - Enhance your LC and GC Productivity in 2010 Certification
  • • Cluster Phenomenax, Belgrade 2010, GC Method Development and Optimization - Course Instructor: Dr.Jörg Baute in 2010 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Serbian
Native
English
Professional Proficiency
Croatian
Full Proficiency
Bosnian
Full Proficiency

Work Preferences

  • Locations I am interested in:
    Belgium France Germany Italy Netherlands Serbia
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    5-10h Hours per week
  • International:
    Yes
  • Availability:
    Jun 2018 : 10%
    Jul 2018 : 30%
    Aug 2018 : 50%
    Sep 2018 : 10%
    Oct 2018 : 50%
    Nov 2018 : 50%

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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