David Fransolet

- Management of analytical methods (viral, biomolecular and cellular) validation activities for the Belgian QC and occasionally Production units (including RTRT pilot project).
- Reference person for any question or input regarding the validation, variability or status of methods within the scope of management (responses to authorities, assessments during change controls, deviations, audits/inspections,...)
- Training and management of supervisors in charge of documentation writing and review of documentation.

Coordination of activities and document writing for the validation of biological analytical methods (viral assay, extraneous agents, ...) - Colaboration with the AMR team on multiple projects implying various methods (ELISA, automation, Lowry,...)

Management of the development and commercialisation of innovative cell cryopreservation products (R&D, stability tests, market analysis,...)