Pharmacist
Education and training
2009
French State Diploma of Doctor of Pharmacy (Pharm. D.)
« Apple Dihydrochalcones : extraction, separation and medical interest » (Discover the thesis, french content)
2006 – 2009
Master of Physical & Chemistry Analysis and Food & Drug Control
College of Pharmacy, University of Strasbourg
2002 – 2009
College of Pharmacy, industry section
College of Pharmacy, University of Strasbourg
2002
French Scientific Baccalauréat with high honors, english major
Lycée Louis Pasteur, Strasbourg
Work experiences
2021 – present
Global Technical Transfer Leader, Roche (Basel, Switzerland)
Global Technical Transfer Leader
2019 – 2021
Transfer Leader, Roche (Kaiseraugst, Switzerland)
Site Transfer Leader
Transfer project management for packaging transfers under GMP environment.
Projects:
- Xofluza powder for oral suspension
- Xofluza tablets
- Crovalimab auto-injector & vials
- PDS Ranibizumab
- Mosunetuzumab vials
- Gantenerumab auto-injectors & vials
2019 (6 months)
Exchange of talent: Global Technical Transfer Leader, Roche (Basel, Switzerland)
Global Technical Transfer Leader
Transfer of NeoRecormon from Roche to a contract manufacturer Vetter (Ravensburg, Germany).
Participation in the Tech Transfer Lead Time Reduction program.
2017 – 2019
Analytical Transfer Leader in Commercial Drug Products Quality Control, Roche (Kaiseraugst, Switzerland)
Analytical Transfer Leader
Project Management of analytical transfers performed under GMP environment.
Coordination of Quality Control teams and SMEs to ensure effective planning and execution of the transfers. Writing of transfer documents.
Projects:
- Successful transfer of clinical and commercial analytical methods from Chugai, Japan, Roche Grenzach and Penzberg, Germany and takeover of ongoing stability studies from Chugai, Japan.
- Responsible for a transfer of commercial analytical methods to a contract laboratory in Belgium.
2014 – 2017
Group Leader inCommercial Drug Products Quality Control, Roche (Kaiseraugst, Suisse)
Management of 3 analytical teams: about 12-15 people (analysts + laboratory supervisors) working in a GMP environment.
Approval of release and stability testing results of commercial parenteral drug products (biologics). Responsible for physical testing of container closure integrity (helium leak test and blue dye test) and capillary electrophoresis. Direct contact with inspectors during inspections (RHI, FDA, internal audit, etc.). Writing of specifications & methods, SOPs, deviation reports.
Projects :
- Implementation of a new qualification concept for equipment qualification.
- Analytical transfers with Genentech South San Francisco, USA and Vetter Ravensburg, Germany.
- Active participation in QC planning, implementation of KPIs (Key Performance Indicators)
2010 – 2014
Lab Supervisor in Quality Control, Roche (Basel/Kaiseraugst, Switzerland)
Management of an analytical team: about 5 laboratory technicians working in a GMP environment, group leader deputy.
Review of release and stability testing results of commercial pharmaceuticals for solids and parenteral pharmaceuticals (biologics) such as physical testing, HPLC, capillary electrophoresis, spectroscopy, SDS-PAGE western blot, IEF, thin layer chromatography Management of qualified equipment (e.g. HPLC, UV and fluorescence spectrometers, capillary electrophoresis, etc.) Analysis of complaints and counterfeits Writing of specifications & methods, SOPs, deviation reports.
Projects:
- Project manager for the development of a web application to plan and organize analytical work in quality control laboratories. Part of an analytical transfer with Genentech South San Francisco, USA.
- Relocation of the GMP laboratory from Basel to Kaiseraugst
2009 – 2010
Lab Specialist in Commercial Drug Products Quality Control, Roche (Basel, Switzerland)
Validation of analytical methods, relations with the registration department to answer questions related to quality, follow-up of Pharmacopoeias.
2009 (6 months)
Industry work experience in Quality Control – Process Robustness Support, Roche (Basel, Switzerland)
Development of a Near Infrared Spectroscopy (NIR) method for the monitoring of a cell culture (simultaneous measure in process of multiple biologic indicators by NIR), development of a Matlab routine for the identification of counterfeit tablets and capsules, Raman spectroscopy.
2008 (6 months)
University laboratory work experience in Analytical Chemistry and Food Science, College of Pharmacy, Strasbourg (UMR 7178 – Eric Marchioni)
Development of a selective extraction and purification method for apple dihydrochalcones using solid phase extraction, high and ultra performance chromatography, UV spectrometry, mass spectrometry.
2008 (6 months)
Hospital internship in the Clinical investigation Center (CIC), Strasbourg Teaching Hospital
Improvement of knowledge of clinical research, completion of case report forms (CRF), investigation of a study on the readability of clinical trial consent forms.
June – August 2007
Fixed term contract (3 months) with Transgène (Biopharmaceutical company, Strasbourg)
– in Quality Control: Verification and improvement of the laboratory equipment’s logbook
in Quality Assurance: Ordering and reorganization of the production equipment’s qualification files.
2005 – 2008
Trainer for Exactétudes (training company, Strasbourg) in Zoology, Genetics, Anatomy and Botany
Preparation and correction of mock exams for the 1st years of Pharmacy.
2005 (6 weeks + 3 months)
Work experience folowed by employment in a Pharmacy (Pharmacie Finkwiller, Strasbourg)
Inventory management (storage, ordering), display labeling, counter service.
Extra-professional experiences
2007 – 2008
Vice-President of “Le Comprimé” (College of Pharmacy newspaper)
Page setting, redesign of the association website.
2006 – 2008
Student elected representative in the council of Strasbourg College of Pharmacy
2005 – 2007
Member of the Pharmacy Student’s Association (AAEPS)
In charge of communication and organization of student parties, creation of posters and video clips. Organization of the Pharmacy Banquet (800 people).
2003 – 2009
Websites realization
- Nogha Consulting (http://www.nogha-consulting.com)
- Section Urbaine (http://www.section-urbaine.fr)
- Le Petit Prince daycare (http://www.kitabasel.ch)
- Le Comprimé (http://www.lecomprime.com)
2003 – 2009
Video realization
- Film presentation of the Good Laboratory Practices at the Faculty of Pharmacy of Strasbourg (see on YouTube)
- Official presentation film of the Faculty of Pharmacy of Strasbourg (see on YouTube)
- DVD of the “Banquet de Pharmacie” 2005, 2006 and 2007 (double DVD box) : full management of the project (filming, editing, creation of the DVD interface and covers)
2001
2nd National Prize from “Concours Lycéen sur les Droits de l’Homme” at the Mémorial de Caen on january 26th 2001
Pleading contest teamed with Frédéric Hecht et Benoît Andlauer : « Lâché au chiens (Delivered to the dogs) » (Discover the pleading,french content).