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Ipsen
- Senior Vice President, Peptides - Head of CMC&E Dreux Site
Boulogne-Billancourt
2013 - maintenant
I - CMC&E Site Director (110 co-workers), including budget and Capex management, HR, facility management, Operational Excellence.
II - Global management of all the Ipsen CMC activities and Clinial Supplies of Peptides & Small Molecules Active Pharmaceutical Ingredients (APIs) and Drug Product Development (resources and projects), from Pre-Clinical Development to Phase III, Filing, Registration and Life Cycle Management. Responsibilities include early formulation activities to support Research teams from Lead identification to Candidate validation, API chemistry, process development and analytics, formulation and process development, novel formulation technologies, device development, analytical development for drug product, stability studies, manufacturing, quality control and logistics (packaging, conditioning, shipping) of clinical supplies:
1 – Early Formulation activities of Lead molecules for proof-of-concept of new Leads and Candidate validation, for all types of molecules (NCEs, peptides, proteins),
2 – Chemistry, process development and analytical development for peptide and small molecule APIs; this includes manufacturing and QC testing of clinical supplies,
3 - Development of oral and injectable drug products for regulatory pre-clinical studies and clinical phases (from PCD to filing and launch) for the Leads in Development, including device development for injectable products; this also includes responsibility for manufacturing, conditioning, packaging and QC testing of clinical supplies,
4 – Generation of the CMC package within the QbD framework (including stability data, Quality Risk Management, analytical package and physico-chemical characterization, QTPP, CQA, CPP, . . . ) for the IMPDs , INDs and filing dossiers of products progressed in Clinical Development (from Phase 0 to Phase III, registration and launch),
5 - Life Cycle Management of the marketed products based on improved manufacturing processes and/or novel formulation technologies (multi-dose products, hSA-free formulations, sustained-release formulations up to 6 months, new strengths and presentations . . .),
6 – Technology, process transfer to commercial manufacturing (internal and external) units for Phase III, industrialization and product launch,
7 – Scientific and technical support to commercial manufacturing for API and DP commercial products: trouble-shooting, root-cause analysis for deviations, process optimization, de-bottlenecking . . .,
8 - Exploratory screening and development of new delivery technologies (e.g. sustained-release formulations, high concentration liquid formulations. . .) and devices,
9 – Clinical supplies manufacturing, control, packaging and shipping to Clinical units for all Ipsen clinical studies worldwide.
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Ipsen
- Vice President Peptides
Boulogne-Billancourt
2011 - 2013
Leading all the CMC activities for development of peptides and small molecules in Ipsen, from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities, based on 5 different sites in Europe and the US, include drug substance (DS) development, scale-up and manufacturing of clinical batches, early formulation to support Research activities, drug product (DP) development and process development, analytical development for DS and DP,as well as QC testing of clinical supplies
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Ipsen
- Vice President, Drug Product development
Boulogne-Billancourt
2011 - 2011
Leading all the CMC activities of drug product development of the Ipsen company for NCEs, peptides, proteins from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities, based on 4 different sites in Europe and the US, include early formulation activities to support Research activities, formulation and process development, analytical development and QC testing of clinical supplies, as well as delivery device development.
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Ipsen
- Senior Director, Head of Drug Product Development
Boulogne-Billancourt
2008 - 2011
Leading all the CMC activities of drug product development of the Ipsen company for NCEs, peptides, proteins from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities include formulation and process development, analytical development and QC testing of clinical supplies, as well as delivery device development.
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Merck Serono
- Director, Head of Pharmaceutical Development - Biotech Products
Lyon
2007 - 2008
Leading the Global Pharmaceutical Development Operations (resources and projects) of the MerckSerono company for therapeutic proteins (hormones, cytokines, fusion proteins, . . .) and monoclonal antibodies, from Pre-Clinical Development (PCD) to Filing and Life Cycle Management
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Serono
- Director, Head of Pharmaceutical Development
2005 - 2007
Leading the Global Pharmaceutical Development Operations and Clinical Production of the Serono company for proteins (hormones, cytokines, fusion proteins, monoclonal antibodies, . . .) and new chemical entities from Pre-Clinical Development (PCD) to Filing & Life Cycle Management
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Ethypharm
- Vice President Research / R&D Director, Europe
SaintCloud
2001 - 2004
Leading the European R&D and Pharmaceutical Development
Operations (resources and projects) of the company from the PCD (including animal studies – PK, tox. studies, . . .) to pilot and cGMP production of clinical supplies, including analytical and QC testing, as well as transfer to industrial sites. Management of the Global Research activities (France and Quebec). Oral dosage formes of NCEs and injectable forms of proteins.
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Mainelab
- R&D Director
1999 - 2000
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Mainelab
- Chief Operating Officer (COO) / Co-funder
1999 - 2004
General management of the company, including:
-Strategic orientations and financial affairs
- Business development – Legal affairs and contract management
- Scientific affairs and project management, IPR,
- R&D Direction
- Human Resources
