Colombes
Expert in pharmaceutical development & CMC
15 years international experience
Professional skills & experience :
- Formulation and process development (solid, liquid, semi-solid dosage forms), scale up and transfer (risk analysis, quality by design)
- Analytical method development & validation
- Line management / Project management / Budget management
- Audit and selection of CRO / CMO / CMDO
- Knowledge in intellectual property and contract management
- Strong organizational & interpersonal skills
- Working with cross-functional teams across EMEA, APAC & Americas
- Knowledge of ICH, EMA, WHO, FDA guidelines & GCP, GLP, GMP, ISO standards
- Writing, review and assessment of CMC sections of MA dossiers and post approval changes
- Writing, review and assessment of pharmaceutical development package for IMPD submissions
- Audit of ASMF and selection of API supplier
Personal skills :
- Strong organizational & interpersonal skills
- Leadership
- Flexibility / availability / proactivity
Mes compétences :
R&D
Qualité
Industrie pharmaceutique
Gestion de projet
Galénique
Chimie analytique
