Broc, Fribourg, Switzerland
Passionate Industrial Pharmacist with over 17 year’s global experience across pharmaceutical manufacturing industry. Specialist in aseptic process and aseptic area I have also a significant experience in manufacturing of solid and liquid forms. I have experience to manage manufacturing program and project. o Team management, manufacturing management o Project management (training GPI) o Aseptic process, Fill Finishing, lyophilization, solid and liquid forms o Event, change control, documentation management o Auditing process (system, process, mock audits, supplier audits, external audits) o Quality norms & standards: GMP, FDA, ISO o Staff training o Budget control and supervision o Sub-contractors coordination
Consultant at Debiopharm
o Manage the manufacturing side of the Moderna’s French o Support the CMO on technical topics (Improvement, investigation, Change Control…) o Support new project implementation on French CMO site o End of contract April 2023
- Manager of Quality system and complaint department (6 direct reports) - Ensure that the Quality System processes are effectively established and maintained - Manage the coordination of the activities including : Deviation , Change control, Document management, audits (Internal and external), confirmed complaints, projects
- Management of project leaders (2 direct reports) - Process Standadization - Gowning Standardization - process improvment - New equipment implementation - Portofolio Project Managment
Main Responsabilities: o Management manufacturing Fill Finishing (2 direct reports / 40 indirects) o Fill Finishing Support Department Management (6 direct report, incl. 3 process engineers) o Process and organization optimization o Improvement compliance management o International and multi-site project, Project managment o Audits and inspections o Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation, Change control
Shire Plc is a Jersey-registered, Irish-headquartered, leading global biotechnology company focused on rare diseases and highly specialized conditions, with nearly 22,000 employees across more than 100 countries. Neuchâtel is a biotechnological production site within the hematology branch. Fill Finishing support Manager Initially started as a Consultant (via AGAP2 AG) then joined Baxter Healthcare (which became Baxalta in 03.2015, then Shire in 06.2016) Main Responsabilities: o Fill Finishing Support Department Management (6 direct report, incl. 3 process engineers) o Process and organization optimization o Improvement compliance management o International and multi-site project o Audits and inspections o Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation, o Back-up management manufacturing Fill Finishing (2 direct reports / 40 indirects).