« Apple Dihydrochalcones : extraction, separation and medical interest » (Discover the thesis, french content)
College of Pharmacy, University of Strasbourg
College of Pharmacy, University of Strasbourg
Lycée Louis Pasteur, Strasbourg
good command of english, written and spoken, TOEIC : 925 (2007)
good command of german, written and spoken
Site Transfer Lead for packaging transfers
Projects: Xofluza Bottles, Xofluza Blisters, Crovalimab autoinjectors & vials, PDS Ranibizumab, Mosunetuzumab vials, Gantenerumab autoinjectors & vials.
Technical Transfer Leader for biological products
Projects: Transfer of NeoRecormon from Roche to a contract manufacturer Vetter (Ravensburg, Germany). Tech Transfer Lead Time Reduction program.
Local Project Manager for analytical transfer performed under GMP environment.
Coordination of QC teams and SMEs to ensure effective planning and execution of transfer. Writing of transfer documents.
Projects: successful transfer lead of clinical and commercial analytical methods from Chugai, Japan, Roche Grenzach and Penzberg, Germany and overtake of ongoing stability studies from Chugai, Japan. Lead of a transfer of commercial analytical methods to a contract laboratory in Belgium.
Management of 3 analytical teams: approx. 12-15 people (analysts + lab supervisors) working in GMP environment.
Validation of analysis from release and stability analysis of commercial parenteral drug products (Biologics). Responsible for the physical Container Closure Integrity testing (helium leakage and blue dye test) and Capillary Electrophoresis. Direct contact with inspectors during inspections (RHI, FDA, intern audit, etc.). Writing of specifications & methods, SOPs, deviation reports.
Projects: Implementation of a new qualification concepts for equipment qualification. Analytical transfers with Genentech SSF and Vetter Ravensburg. Active involvement in QC Planning, implementation of KPIs (Key Performance Indicators).
Management of an analytical team: approx. 5 analysts working in GMP environment, Group Leader deputy.
Review of the analysis results from release and stability analysis of commercial drug products for solids and parenteral drug products (Biologics) such as physical testings, HPLC, capillary electrophoresis, UV, SDS-PAGE western blot, IEF, TLC. Management of qualified equipment (e.g. HPLC, UV and fluorescence spectrometers, capillary electrophoresis, etc.). Analysis of complaints and counterfeits. Writing of specifications & methods and SOPs, deviation reports.
Projects: Project Leader for the development of a web-application aimed to plan and organize the analytical work in the QC labs. Part of an analytical transfer with the Genentech SSF. Relocation of the GMP lab from Basel to Kaiseraugst.
Validation of analytical methods (e.g. HPLC): redaction of plans and reports, execution of the tests. Transfer of analytical methods (e.g. dissolution, HPLC): execution of the tests. Relations with regulatory department to answer questions concerning quality. Follow-up of the different Pharmacopoeia: redaction of a newsletter for the QC.
Development of Near-Infrared (NIR) Spectroscopy methods for cell-culture monitoring (simultaneous measure in process of multiple biologic indicators by NIR). Raman and NIR spectroscopy (e.g. counterfeits). Development of a Matlab® program for capsules, tablets and packaging counterfeits visual identification.
Development of a selective extraction method of dihydrochalcones from food matrix using solid phase extraction, High & Ultra Performance Liquid Chromatography, UV spectroscopy and mass spectroscopy. Lab work used for the thesis work “Apple Dihydrochalcones : extraction, separation and medical interest”
Improvement of knowledge in clinical research, filling of case report forms (CRF), investigation of a study on readability of clinical trial consent forms.
– 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.
Preparation and correction of mock exams for Pharmacy 1st year students.
Stock management (storage, order, reception…), counter service.
Page setting, redesign of the association website (http://www.lecomprime.com).
In charge of communication and student parties organisation, conception of communication media Organisation of the “Banquet de Pharmacie” (800 people).
Official presentation movie for Strasbourg College of Pharmacy (http://www-fac-pharma.u-strasbg.fr)
The Good Laboratory Practice in Strasbourg College of Pharmacy (http://www.canalc2.tv/podcast/filmbpl.mov)
DVD of the “Banquet de Pharmacie” 2005, 2006 and 2007 (double DVD box) : full management of the project (filming, montage, creation of the DVD interface and jacket…)
Pleading contest teamed with Frédéric Hecht et Benoît Andlauer : « Lâché au chiens » (Discover the pleading, french content).
Travels : Costa Rica, Nepal, Thailand, Hawaii, Myanmar, Sri-Lanka, United States, South Africa, Egypt, Turkey, Greece, Italy, Spain, Irland…
Macro Photography (insects and flowers) (see my Flickr Gallery)
Creation of websites and websolutions