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Denis BASCOUL

BERNE

En résumé

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

Entreprises

Pas d'entreprise renseignée

Formations

Pas de formation renseignée

Réseau

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