I am leading a team that manages the chemical and analytical development. We are in charge of the development, the optimization and the transfer of industrial production processes.
This covers:
- The creation and adaptation of the synthesis processes to the production,
- The follow-up of the development until the validation of the first production batches,
- The analytical development with the optimization of the validation of the analytical methods, mainly HPLC,
- The qualification of new sources of raw materials or critical reagents for intermediate steps of synthesis,
- Studies and resolution of some production issues,
- Writing of chemical and analytical parts of regulatory documents (DMF, CTD, CEP),
- Monitoring of certifications ISO 14001 and 9001 and FDA agreement,
- Collaborate and communicate with the teams of R&D in the group,
- Drive process transfer between production sites.
In these missions, my laboratory can demonstrate precise measurements of objectives. I work commonly in international environment with multiple collaborations between R&D laboratories or with our customers and providers in Germany, Netherland, Italy, Israel, and France.
Mes compétences :
Organic chemistry
Project management
Process development
PMP certification
Fine chemistry
Technology transfer
Process improvement
Process validation
QA and HSE management systems
GMP
Pharmaceutical industry
Technical writing
Report writing
R&D
