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Moderna
- Sr. Specialist Manufacturing Sciences and Technology – International Fill/Finish as Contractor
Production | Basel
2021 - 2023
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
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Biorad
- Quality Manager
Production | Cressier
2019 - 2021
o Manager of Quality system department (6 direct reports)
o Ensure that the Quality System processes are effectively established and maintained following medical device regulations (ISO 13485, MDSAP, IVDR)
o Responsible for activities including : Deviation , CAPA, Change control, Document management, audits (Internal and external), confirmed complaints, projects
o Project Manager for International and multi-site project
o Process and organization optimization
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Takeda
- Manufacturing Project Manager
Production | Neuchâtel - Suisse
2018 - 2019
* Process and organization optimization on the global manufacturing
* Improvement compliance management on the global manufacturing
* International and multi-site project management (2 direct reports, process engineer)
* Manufacturing Tech transfer responsible (2 direct reports)
* Audits and inspections (FDA, CFDA, EMEA, Brazil, Japan, Korea, Russia...)
* Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation.
Initially started as a Consultant (via AGAP2 AG) then joined Baxter Healthcare (which became Baxalta in March 2015, then Shire in June 2016 and finally Takeda in January 2019)
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Takeda
- Head of Fill Finishing
Production | Neuchâtel - Suisse
2017 - 2017
* Management manufacturing Fill Finishing (8 direct reports incl. 3 process engineers and 2 supervisors / 40 indirect)
* Process and organization optimization
* Improvement compliance management
* International and multi-site project
* Audits and inspections (FDA, CFDA, EMEA, Brazil, Japan, Korea, Russia...)
* Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation.
Initially started as a Consultant (via AGAP2 AG) then joined Baxter Healthcare (which became Baxalta in March 2015, then Shire in June 2016 and finally Takeda in January 2019)
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Takeda
- Fill Finishing support Manager
Production | Neuchâtel - Suisse
2014 - 2017
* Process and organization optimization
* Improvement compliance management
* International and multi-site project
* Audits and inspections
* Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation,
* Back-up management manufacturing Fill Finishing (2 direct reports / 40 indirects).
Initially started as a Consultant (via AGAP2 AG) then joined Baxter Healthcare (which became Baxalta in March 2015, then Shire in June 2016 and finally Takeda in January 2019)
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Agap2
- Consultant
Basel
2014 - 2015
Process and organization optimization
* Improvement compliance management
* International and multi-site project
* Audits and inspections
* Quality Systems: Deviations, OOS, OOT, CCR, CAPA, SOP, Qualification & Validation,
* Back-up management manufacturing Fill Finishing (2 direct reports / 40 indirects).
Initially started as a Consultant (via AGAP2 AG) then joined Baxter Healthcare (which became Baxalta in March 2015, then Shire in June 2016 and finally Takeda in January 2019)
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Altran Suisse
- Industrial Pharmacist consultant
Lausanne
2012 - 2014
I worked on different topics for several companies :
* Bracco (December 2012)
Analyzed the current documentation and process related to manual visual and semi-automatic visual inspection in aseptic process and suggested some process optimizations prior to their Brazil inspection.
* Medtronic (April to July 2013)
Focused on Lean manufacturing, manufacturing processes analysis with regard to medical device regulation (ISO 10012, 13485), GMP and FDA best practices. Facilitated workshops to analyze current calibration processes and elaboration of new processes using lean methodology. Performed Process assessment of changes to aseptic areas (white room regulation and impacts on area changes).
* Anteis (November 2013)
Audit sterilization qualification.
* Merck Serono
medical device (GBF), 10-month assignment Our client needed a pharmacist to check quality documentation from Supplier, check efficiency of
Medical device manuals then coordinate regulatory document's translation.
GMP and FDA expertise and performed translations for regulatory documents.
*Vifor Pharma
Our client experienced issues with its management organization within the manufacturing department. They were facing a recurrence of non-conformity and CAPA that generated a work overload. I was in charge of the solid manufacturing department which was facing an outbreak and a recurrence of non-conformity and CAPA (Corrective Action/Preventive Action) generators of overload working support for pharmaceutical documentations (batch doc, logbook review, process) for the management and the operators in 3x8. My mission was focused on process optimization and people safety and 3 team managers, 25 operators were reporting into me.
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Laboratoire Weleda
- Manufacturing Pharmacist Assistant
Production | HUNINGUE
2009 - 2012
Leading the manufacturing departments (primary and secondary packaging) for injectable drugs and labels, as well as aseptic processes (autoclave, depyrogenation and aseptic filtration).
Managing 3 team leaders, 8 technicians and 8 operators.
Main Responsabilities:
* Project management in a multi-disciplinary environment (implement new packaging manufacturing line and qualification (IQ, OQ, PQ) with qualification/validation department)
* Staff training
* Sub-contractors coordination
* Planning
* Budget control and supervision
Achievements:
* Follow-up of the rebuilt projects in manufacturing areas with controlled atmosphere as well as equipment.
* Organized news process of manufacturing, primary and second injectable packaging
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Glaxosmithkline
- Manufacturing Manager
Production | Notre-Dame-de-Bondeville (76960)
2008 - 2009
Management and quality oversee within the manufacturing department (aseptic process, and sterilization by autoclave, cooker and filtration), incl. primary and secondary packaging.
Management of 50 technicians/ operators and 1 team leader.
Main Responsabilities:
* Staff Supervision and Training
* Batch document control, investigate and updates the manufacturing documents, improvement processes.
* Planning
* Lean project
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Sophartex
- Manufacturing Manager
Production | Vernouillet
2007 - 2007
Management of environment-security department and manufacturing department.
Liquid, solid and powder forms (manufacturing, primary and second packaging).
Management of 20 operators
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Sophartex-Synerlab
- Responsable sécurité/environnement et pharmacien adjoint de production
Autre |
2007 - 2007
Responsable sécurité/environnement et pharmacien adjoint de production au sein du laboratoire Sophartex-Synerlab (Vernouillet 28). Evaluation et amélioration des conditions de travail, notamment vis-à-vis des agents chimiques dangereux. Encadrement, gestion en totale autonomie, des opérateurs et des incidents sur ligne.
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Servier
- Stagiaire
Suresnes
2006 - 2006
Stage de fin d’étude et thèse d’exercice dans le service Hygiène-Sûreté-Sécurité-Environnement des Laboratoires Servier Industrie (mise en place de la méthodologie, des mesures et de leurs interprétations pour les produits chimiques dangereux en atmosphère de travail dans le cadre des lois de 2001 et 2003).
