Experience

Lonza Netherlands, former PharmaCell

• Netherlands
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Technical Expert QC

  • May 2017 - Feb 2023

  Geleen

• Technical Expert Quality Control

  • Nov 2014 - Feb 2023

  Maastricht Area, Netherlands Assist manager QC to manage and monitor the implementation of cGMP within the QC dept. Manage laboratory equipment service, calibration and qualification activities in collaboration with Quality Engineering. Manage the company stability program according to ICH guidelines. Manage new product development testing in support of clinical protocols and marketing authorization applications. To take part and be the QC Subject Matter Expert in audits performed by Regulatory Bodies. Approval of GMP… Show more Assist manager QC to manage and monitor the implementation of cGMP within the QC dept. Manage laboratory equipment service, calibration and qualification activities in collaboration with Quality Engineering. Manage the company stability program according to ICH guidelines. Manage new product development testing in support of clinical protocols and marketing authorization applications. To take part and be the QC Subject Matter Expert in audits performed by Regulatory Bodies. Approval of GMP documents and QC related documentation. Manage QC method transfer for new projects.

• Manager Quality Control

  • Aug 2013 - Oct 2014

  Maastricht Area, Netherlands

• Team Leader Quality Control

  • Mar 2011 - Jul 2013

  Maastricht Area, Netherlands Main responsibilities: manage a team of 2-5 analysts. Responsible for all QC assays (safety, potency and identity tests) and documentation compliant to GMP. Tests involve cell biological and microbiological techniques. Review and approval of QC related batch / unit documentation Writing and proactive follow-up of Non-Conformances, Planned Deviations and Corrective And Preventive Actions Writing SOPS and GMP documentation Trending assays and analytical methods Management and… Show more Main responsibilities: manage a team of 2-5 analysts. Responsible for all QC assays (safety, potency and identity tests) and documentation compliant to GMP. Tests involve cell biological and microbiological techniques. Review and approval of QC related batch / unit documentation Writing and proactive follow-up of Non-Conformances, Planned Deviations and Corrective And Preventive Actions Writing SOPS and GMP documentation Trending assays and analytical methods Management and independent trouble-shooting for QC activities as shift supervisor Cross-departmental cooperation regarding technology and method transfer from clients into the QC department and preparing all work for routine testing to ensure efficient processing and timely release of final product

• Senior Research Associate

  • Apr 2009 - Mar 2011

  In my current position as Senior Research Assistant at PharmaCell my main responsibilities are: to adapt R&D based assay setup and cell culture to cGMP based guidelines (EMEA/ICH) for the implementation of cell based products that are used for clinical trials and final clinical formulations. Writing and revise documentation related to cGMP. Assist the QC department in implementing QC tests and related documentation. Production of proteins in mammalian cell cultures and if requested the Down… Show more In my current position as Senior Research Assistant at PharmaCell my main responsibilities are: to adapt R&D based assay setup and cell culture to cGMP based guidelines (EMEA/ICH) for the implementation of cell based products that are used for clinical trials and final clinical formulations. Writing and revise documentation related to cGMP. Assist the QC department in implementing QC tests and related documentation. Production of proteins in mammalian cell cultures and if requested the Down Stream Processing (DSP) and protein chemistry related tasks. Perform large scale culture of human cells under cGMP guidelines in a B-class area (for instance in cell stacks or a wave bioreactor).

• Quality Engineer (ad interim)

  • Apr 2010 - Nov 2010



Dyax

• Biotechnology Research
• 1 - 100 Employee

• Staff scientist I

  • Jul 2001 - Jul 2008

  This position included antibody /protein and enzyme purification and characterization, enzyme kinetic measurements (Ki, IC50) with lead antibodies, sFab production in and purification from E.coli. I participated as a core team member for the biochemistry team in project teams which included: communication of project timelines and demands to the functional area, delivery of data and products on time within quality criteria and to contribute in team discussions over Video Link with the US.