> Project management
> Drug development
Project Leader Donstiennes, Thuin, Belgium
Since August 2015
> Management of stability studies and QC testing projects on Biologics (mAbs, ADCs, proteins, …) in a GMP environment and back-up of the Team Manager. > Initiation of the projects in collaboration with the customers, participation to the preparation of budgets, planning/scheduling of the work including timelines/deadlines, ensuring smooth communication among all stakeholders, tracking progress of the projects, reviewing of technical documents (methods, protocols, ...), writing of deviation reports, management of OOS/OOT results, checking of the final reports, ...
> Parallel management of 4 projects covering the majority of analytical techniques required for stability studies/QC testings (involving about 20 people) and of about 10 smaller projects.
Technical Leader Donstiennes, Thuin, Belgium
April 2013 --- July 2015
> Management of method validation projects on Biologics (mAbs, ADCs, proteins, …) according to ICHs in a GMP environment. > Supervision of the analysts involved in the projects, following up of technical aspects of the analyses (troubleshooting), writing of deviation reports, communication with customers, checking of the final reports and raw data, ...
> Validation of about 15 analytical methods (cell-based assays and immunoassays).
March 2012 --- March 2013
> Development, validation and application of analytical methods on Biologics (mAbs, ADCs, proteins, …) in a GMP environment.
> Writing of the final reports.
Final work in molecular and cellular biology
February 2011 --- September 2011
Subject: protein interactions involved in Crohn’s disease.
Skills and Expertise
Validation of analytical methodsCell cultureCell-based assaysELISASDS-PAGEWrite final reportsReview final reportsCommunicate with sponsorGMPsPharmaceutical industryLife SciencesBiotechnology industryproject managementQuality control processStability studiesProtein characterisationcell biologymolecular biologyDevelopment of analytical methods
Master bioengineer in Chemistry and bioindustry from Université de Liège, Gembloux Agro-Bio Tech in 2011