Ses Talents
Années d'experience:
10-15 ans
Aptitudes:
Actif et dynamique, Pragmatique, Organisé, Approche global, Esprit d'analyse et critique, Flexibilité, Recherche d'information
Langues:
{{ ''|langNameByCode}} - Native or bilingual proficiency
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Réalisations:
I hold a PharmD and a PhD in Vaccinology from the University of Strasbourg (France) and I have 10+ years of experience in R&D in the pharmaceutical and biotech industries, including collaborations or positions in companies/institutions of various sizes (large, medium and small).
Since August 2019, I have been acting as an independent consultant. I support companies, innovative startups and research organizations in the development of their product candidates, particularly in fields like Vaccine Development, Innovative Drug Products & Formulation/Delivery of Biologics, from discovery to initiation of clinical trials (Human & Animal Health). My service offer includes (i) state-of-the-art / strategic foresight (science, technology, regulatory watch, competitive Intelligence, commercial intelligence), (ii) drafting of scientific & specific documents (research proposals, research papers & review articles, reports, Quality documents…), (iii) research and identification of new targets, products or processes, (iv) implementing strategy for product-candidate development, (v) Project management, supervision & coordination, (vi) expertise support in CMC-related activities, (vii) strategic review & evaluation, and (viii) technical support.
I am looking for (i) part-time, short-term or long-term projects, as expertise and technical support, and (ii) for new business opportunities, as partner, for an innovative start-up being launched in the area of Biotech/Pharma.
Functional competencies :
. R&D Strategy Development
. Project Management & Coordination
. Expertise & Technical Support
. Strategic Foresight
. Draft skills
Fields: Pharma, Biotech
Main areas of expertise : Vaccine Development, Innovative Drug Products, Formulation/Delivery of Biologics
Scientific skills :
Live-attenuated vaccine, Peptide- and protein-based vaccine, Conjugate vaccine. Prophylactic vaccine, Therapeutic vaccine. Immunoadjuvant. Nano- and microparticle formulation. Drug delivery. Freeze-drying of vaccine formulation. Characterization of vaccine formulations (physic- ochemical, biochemical, bioanalytical, stability studies...). Cell culture (primary culture, cell line and parasite culture). In vivo studies in mice. Immunomonitoring. Antibody functionality. Infectivity assays...
Additional skills :
. Pharmaceutical Development: Formulation, Potency assay development, Optimization and Scale-up (pilot-scale batches) of bioproduction process, Upstream & Downstream process development, Stability testing, Identification & management of CRO/CDMO...
. QA/QC: Practical knowledge of standards: GLP/cGMP regulations, ISO 9001, ICH, FDA, EMA, WHO guidelines/guidance documents, Pharmacopoeial standards. Drafting of Quality documents, Qualification & Validation of analytical methods...
. Entrepreneurial experience: Marketing, Communication, Management and supervision of innovative projects, Strategic foresight