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Admissions
- Consultant CMC
Gonfreville l'Orcher
2011 - maintenant
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LILLY France
- Process validation manager
2003 - 2005
, Process validation manager; LILLY France manufacturing parenteral plant (65 people, 14 managers to manage)
* Management of technological transfer, excipient & bulk change projects, troubleshooting activities.
* Management of process validation, process optimisation & fiabilisation program.
* Organisation of a technical interface with bulk sites & R&D departments.
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LILLY France
- Process validation manager
2003 - 2005
, Process validation manager; parenteral plant (65 people, 14 managers to manage)
* Management of technological transfer, excipient & bulk change projects, troubleshooting
activities.
* Management of process validation, process optimisation & fiabilisation program.
* Organisation of a technical interface with bulk sites & R&D departments.
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FOURNIER
- Preformulation manager
1997 - 2003
, Formulation - (4 junior managers, 5 technicians):
* Management of NCE physicochemical characterisation and pharmaceutical development
activities : stability studies, polymorphism study, crystallography study.
* Management of formulation activities on NCE projects (phase I to phase III) : parenteral DDS,
oral DDS, freeze drying products ; project planning, preformulation and formulation reports,
technical documents for IND and NDA.
* Pharmaceutical project leader : coordination of pharmaceutical development activities,
management of multidisciplinary project team (analytic, galenic, regulatory, clinic,
pharmacocinetic, toxicologic), project planning elaboration, budget follow up.
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FOURNIER
- Preformulation manager
1997 - 2003
, Formulation - preformulation manager; R&D site FOURNIER laboratory (4 junior managers, 5 technicians):
* Management of NCE physicochemical characterisation and pharmaceutical development activities : stability studies, polymorphism study, crystallography study.
* Management of formulation activities on NCE projects (phase I to phase III) : parenteral DDS, oral DDS, freeze drying products ; project planning, preformulation and formulation reports, technical documents for IND and NDA.
* Pharmaceutical project leader : coordination of pharmaceutical development activities, management of multidisciplinary project team (analytic, galenic, regulatory, clinic, pharmacocinetic, toxicologic), project planning elaboration, budget follow up.
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FLAMEL TECHNOLOGIES
- Formulation manager
1996 - 1997
, Formulation manager; FLAMEL TECHNOLOGIES French drug delivery company:
* Organisation of the galenic department : laboratory elaboration (250 m2 laboratories), equipment order, people recruitment & formation (3 senior managers, 8 technicians).
* Projects coordination within multidisciplinary experts team (physicochemist, physician, chemist, polymerist, doctor) for international companies (6 to 8 projects to lead) : planning elaboration, pharmaceutical development reports.
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FLAMEL TECHNOLOGIES
- Formulation manager
1996 - 1997
delivery company:
* Organisation of the galenic department : laboratory elaboration (250 m2 laboratories),
equipment order, people recruitment & formation (3 senior managers, 8 technicians).
* Projects coordination within multidisciplinary experts team (physicochemist, physician,
chemist, polymerist, doctor) for international companies (6 to 8 projects to lead) : planning
elaboration, pharmaceutical development reports.
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SMITHKLINE BEECHAM France
- Senior manager
1994 - 1996
, senior manager within the pharmaceutical development department; manufacturing site
* Development pharmaceutical projects management for France & Europe (8 to 10 projects) ; coordination of galenic and analytical activities : stability studies, clinical batches manufacture, industrial transfer, troubleshooting.
* Management of the development activities : 2 managers, 7 galenic and analytical
technicians.
* Elaboration of part II regulatory dossiers.
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SMITHKLINE BEECHAM France
- Senior manager
1994 - 1996
, senior manager within the pharmaceutical development
department; manufacturing site
* Development pharmaceutical projects management for France & Europe (8 to 10 projects)
coordination of galenic and analytical activities : stability studies, clinical batches
manufacture, industrial transfer, troubleshooting.
* Management of the development activities : 2 managers, 7 galenic and analytical
technicians.
* Elaboration of part II regulatory dossiers.
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DOW CORNING
- Project manager
Seneffe
1989 - 1994
* Elaboration of new oral DDS based on silicone ; management of the projects
linked to this new technology for multinational companies.
* Development of new formulations and new polymers for this technology.
* US technological transfer of the technology : people formation, congress and seminar participation.
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CORNING
- Responsable formulation
Bagneaux-sur-Loing
1989 - 1994
* Elaboration of new oral DDS based on silicone ; management of the projects
linked to this new technology for multinational companies.
* Development of new formulations and new polymers for this technology.
* US technological transfer of the technology : people formation, congress and seminar
participation.
