Développement pharmaceutique
8 septembre 2008
Ile de France
IDM Pharma (Paris) :
Associate Director Process Development, Leading the European Process Development group (2003- 2008):
- Manage and supervise a multidisciplinary team of 8 collaborators composed of scientists, engineers and research associates.
- Define Process Development activity strategy, Manage budget (1 M € annual), objectives and timelines in accordance with the requirements of the projects.
- Report to the global Process Development Director and the General Manager Paris with cross- reporting to Project Leaders.
- Acting General Manager when General Manager is absent.
- Coordinate transition from Research to Development and from Development to Manufacturing and Quality Control Units.
- Conduct pre-clinical studies to support regulatory submissions in coordination with Manufacturing, Quality Assurance, Regulatory and Clinical units.
- Write non-clinical and CMC section for AFSSAPS, MHRA, EMEA and FDA submissions.
- Develop acceptance and release criteria for Phase I, II and III clinical trials of biotech / pharma products in oncology (melanoma, bladder cancer and osteosarcoma).
- Design, optimize and automate production processes for therapeutic cell drugs.
- Harmonize the processes and testing performed at the two manufacturing sites (Europe, USA).
- Manage meetings and communication within global Process Development organization (Europe, USA), project teams and other operational units.
- Provide scientific expertise for product development, clinical trial design, due diligence and IP strategy.
- Involved in partnership and due diligence discussions.
- Co-manage FDA Pre-Approval Inspection.
Senior Scientist (2002-1999), leading the Cell Technology platform:
- Managed a team composed of an engineer and a research associate.
- In charge of production and characterization of human macrophages and dendritic cells from healthy donors
- Studied the influence of aphereses components on the differentiation of monocytes into dendritic cells.
- Developed apheresis collection standards compatible with human dendritic cells and macrophages differentiation.
- Characterized dendritic cell sub-populations and studied the influence of cytokines on dendritic cell differentiation.
Unité d’Immunologie Cellulaire et Clinique, Inserm 255, Institut Curie (Paris). PhD Internship with Dr. J.-L. Teillaud as supervisor (1995-1999)
Subject : Characterization of monocyte derived cells : macrophages and dendritic cells for therapeutic use.
- Program developed in close collaboration with IDM Pharma within a CIFRE funding
- Program developed within a European program, Cellular Vaccine.
- Training of laboratory trainees.
- Scientific and technological survey.
Lycée Horticole de Saint Germain en Laye (1995), taught Physics and Chemistry.
Centre de Recherche en Photo-biophysique, Université du Québec à Trois Rivières (Canada). Master of Sciences Internship under the supervision of Pr. Arbour et Pr. Boucher (4 months, 1994)
Subject : Color discrimination by forward and reverse photocurrents in Bacteriorhodopsin-based photo-sensor.
EDUCATION
1995/1999 PhD in Immunology, Université de Technologie de Compiègne
1991/1994 Master of Sciences in Chemical Engineering, specialized in Organic
chemistry, Ecole Nationale Supérieure de Chimie de Montpellier
English : Fluent
References and Publications : Available upon request
EXPERTISE
Project Management
Team Management
Process Development
Conduct Pre-Clinical CMC studies
Acting General Management
SPECIALITY FIELDS
Immunology
Cell Therapy
Vaccine
Oncology
Small molecules
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