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Summary

cmc - Expert interested in jobs in the (bio)pharmaceutical, chemical and biotechnological sector?  i am looking for mangement - team Leader jobs either in production or Process development.      

 

 

currently, i am a Scientist team Leader at ablynx responsible for managing a small team of Scientist developing Analytical methods, the Formulation and the Characterization of protein therapeutics (ds & dp). in my role, i also cooridinate for certain projects the cmc Pharmaceutical Development and represent cmc in cross functional teams. in addition, i  organize and supervise project activities with external partners, chair project meetings and organize and supervise wet Lab work.

i have an active management style, using my charisma, confidence and project authority in a way that draws my team together behind our common goal. i motivate them by inspiring them and showing them that their contributions make a real difference.  

in previous jobs,  i have build up expertise in protein production and Purification, more specifically enzymes, recombinant Proteins and Monoclonal Antibodies. i have designed industrial processes optimizing the Fermentation, Purification and final buffer Formulation for Proteins and antibodies applied in In Vitro Diagnostics. as the head of biomanufacturing in a sme active in the In Vitro Diagnostic sector, i was also responsible for implementing  and improving the Quality Assurance system.

apart from protein production and Fermentation, i am also experienced in Protein Engineering and biocatalysis. i have engineered enzymes during my phd to alter the substrate specificity and the stability. i have also developed industrial biocatalytic processes in the starch industry starting at the Lab scale and scaling the process to final industrial scale.

 

Experiences

Current Experience

  • Scientist - teamleader CMC

    gent
    Since February 2016
    people management
    • People management
      • Manage a team of scientists and lab technicians
      • Support and inspire team members
    • Analysis, characterization and formulation of protein therapeutics
      • Analytical method development
      • Formulation of DS and DP (different routes of administration)
      • Characterization of product related variants and process related impurities
      • Support CMC process development (USP and DSP)
    • Early and late stage pharmaceutical developmen
      • Represent CMC in interdisciplinary project teams
      • Summarize and report results
      • Contribute to regulatory dossiers (CMC-sections)
      • Support all departments with an overall product and process understanding
    • Project management
      • Organize and supervise project with external partners
      • Organize and chair project meetings
      • Organize and supervise wet lab work

     

     

  • Head of Biomanufacturing


    Since March 2014
    Monoclonal Antibodies

    * Development and scale-up of production processes for recombinant proteins and monoclonal Antibodies

    * Continuous improvement of processes and quality system

    * Transfer of processes to CMO

    * Implementing and improving quality assurance system

Past Experience

Personality

Self Assessment :
Creative thinkingProblem solvingAssertivenessSociabilityFlexibilityInnovative thinkingOrganizationResponsibilityStrategic thinkingResult OrientedSelf-confidenceStriving

Knowledge

Self Assessment :
people managementChemistry, Manufacturing, and Controls (CMC)FormulationAnalytical Chemistry
LinkedIn Assessment :
Biochemistrymolecular biologyEnzymesBiocatalysisAnalysisProtein EngineeringProtein ExpressionScientific WritingBioinformaticsProject ManagementEnzyme KineticsPurification

Skills and Expertise

Self Assessment :
Build the CMC development plan Interpret data Report data Technology researchChemistry Manufacturing and Controls (CMC) activitiesCoach staffCoordinate CMC-activitiesPeople managementproject management

Education

  • Ph.D. in Applied biological sciences from Ghent University in 2012
  • Summer school in Glycosciences from The Graduate School VLAG in 2008
  • Master's degree in Bioengineering from Ghent University in 2007
  • Exchange program Biorenewable resources in from Iowa State University in 2006

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
French
Elementary Proficiency
Dutch
Native

Area / Region

Gent, België

Others

Driving License
  • Yes

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