BERNE
Downstream Process Engineer at Crucell (Johnson & Johnson)
janvier 2010 – Poste actuel (2 ans 5 mois) Bern (Switzerland)
Downstream Process Engineer in Late Stage Development unit (Pilot plant)
Technology transfer and scale up of virus purification processes for clinical trials in a full cGMP manufacturing environment.
- Perform and support the technology transfer from lab to pilot plant, scale-up, GMP compliant production of clinical material.
- Coordinate and support qualification/validation activities of facility/equipment to meet cGMP requirements for production of clinical trial material.
- The techniques used for the process execution are clarification, tangential flow filtration, filtrations, ultracentrifugation and inactivation.
- Extensive work on isolator system: VHP decontamination cycle development, process optimization, documentation writing.
- Writing of cGMP compliant documentation (MBRs,SOPs,URS,etc.) and study plans/reports related to the pilot plant activities.
Mes compétences :
Biotechnologies
Purification
Pas d'entreprise renseignée
Pas de formation renseignée
