Experience

Janssen Vaccines & Prevention B.V.

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Scientist

  • Apr 2021 - Present

  Transition of products/projects from early phase to late phase and commercial space. • Execution of CMC objectives according phase appropriate regulatory requirements• Method development, commercial validation, and transfers to internal and external CRO/CMO according to the relevant regulations (EU, US and ICH), pharmacopoeias, internal SOPs• IND/IMPD, BLA, MAA submissions, post-marketing authorization commitment. Authoring and reviewing of Module 3• Writing, maintenance, and submission of regulatory CMC documents in line with current guidelines and regulations• Interactions with Heath Authorities (briefing books, Scientific Advise)• Transition of products/projects from early phase to late phase and commercial space in multidisciplinary teams• Life Cycle Managements of methods, reports, and relevant documentation• People management in multidisciplinary and cross functional groups• Line manager of people with different level and ambitions Show less

• Scientist

  • May 2020 - Jun 2021

  - Transition of products/projects from early phase to late phase and commercial space- Commercial validation and transfers according to the relevant (EU, US and ICH) regulations, pharmacopoeias, internal SOP - BLA, MAA submissions, post-marketing authorization commitment



Janssen Biologics B.V., Johnson and Johnson

• Leiden

• Scientist

  • Aug 2016 - May 2020

  Application of analytical science to support phase III and marketed products. Method improvement, transfer and validation in a GMP environment. Capillary electrophoresis SME. Coordination of QC department. Lead and support scientific and compliant projects. Analysis of Antibody. Application of analytical science to support phase III and marketed products. Method improvement, transfer and validation in a GMP environment. Capillary electrophoresis SME. Coordination of QC department. Lead and support scientific and compliant projects. Analysis of Antibody.



Leiden University Medical Center

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Post-doc

  • Nov 2012 - Apr 2016

  Researcher in Metabolomics in the context of renal disease, infections and genetic diseases. Centre for Proteomics and Metabolomics LUMC, Leiden.Tasks:Leading and coordination of research projects in the context of renal, genetic and infectious diseasesManagement and maintenance of LC-UV/MS (QqQ),q-ToF, Ion-trap), GC-MS/FIDAnalysis of body fluids and tissueAnalytical method development and validationAnalysis of small molecule, peptide, proteins and glycoproteinSupervision of technicians, master and HALO studentsWriting of laboratories procedures and scientific reportsStatistical data analysis (medical statistics, multivariate statistical analysis) using software like , SPSS, Umetric Simca, R Show less

• PhD student

  • Nov 2008 - Oct 2012

  Researcher in metabolomics applied to urinary tract infection. PhD Student at the Department of Infectious disease and Centre for Proteomics and Metabolomics.Tasks:Analytical Method DevelopmentRunning and management of LC-UV/MS (QqQ),q-ToF, Ion-trap), GC-MS/FIDAnalysis of body fluidsAnalysis of small molecule, peptide, proteinsSupervision of master and doctorate studentsWriting of laboratories procedures and scientific reportsStatistical computing with programming languageDatabase management Show less



Universidad de Almería

• Spain
• Higher Education
• 700 & Above Employee

• Fellowship student

  • Feb 2008 - Oct 2008

  Researcher in Food analysis. University of Almeria, Spain Tasks: Analysis of pesticide residues in food matrices (fruit, vegetables and their processed product) Analytical methods development and validation For GC-MS (ion-trap) and LC-MS (ToF, QqQ) Researcher in Food analysis. University of Almeria, Spain Tasks: Analysis of pesticide residues in food matrices (fruit, vegetables and their processed product) Analytical methods development and validation For GC-MS (ion-trap) and LC-MS (ToF, QqQ)



Consiglio Nazionale delle Ricerche

• Italy
• Research Services
• 700 & Above Employee

• Junior Researcher

  • Jan 2007 - Dec 2007

  Research analyst at the NCR-National Council of Research, Institute of Atmospheric Pollution Tasks: Analysis of pollutants (dioxins-like molecules, volatile organic compounds, PAH) in industrial waste Running and maintenance of GC-MS (Ion-trap, Q, magnetic sector) Writing scientific report and analysis reports for third parties Research analyst at the NCR-National Council of Research, Institute of Atmospheric Pollution Tasks: Analysis of pollutants (dioxins-like molecules, volatile organic compounds, PAH) in industrial waste Running and maintenance of GC-MS (Ion-trap, Q, magnetic sector) Writing scientific report and analysis reports for third parties