Lucie Mottier
CMC project manager
CMC, chemistry, formulation and analytical development.
15 contactsI am in responsible of the CMC activities for the products in co-development that includes new chemical entitites, combo product, solid dosage form, steril or inhalation products.
2005 - 2006Phytopharm is a virtual biotechnology company based in Godmanchester (England).
I am in charge of the formulation development of new chemical entities.
1.Responsible of planning and budget for all formulation and analytical activities related to the development of new chemical entities, coordination with pre-clinical and clinical departments.
2.Management of pre-formulation, formulation studies and manufacture for clinical studies. Coordination with outsourcing activities (planning, budget, technical follow up and reporting). Development of liquid and solid oral formulations for pre-clinical and clinical (phase I and II) projects.
3.Redaction of the quality part (drug product) of the Investigational Medicinal Product Brochure (IND)
4.CRO and CMO prospecting
2000 - 2004(Sophia Antipolis - 06)
1.Project leader: coordination of project with internal directors and team player, and external partners and customers from the evaluation to the clinical trial steps including regulatory documentation.
2.Formulation project manager: responsible for the conception, development and reporting of innovative formulation and formulation technology projects, mainly modified release solid dosage form to meet internal or external customer requirements.
3.Management of the formulation and technology scale up and transfer
4.Management of a technician-team
5.Redaction of quality policies as a complete standard GMP batch file
6.Responsible for the sourcing, installation, validation and maintenance of the lab-equipment
7.Drove changes in procedures, or organisation to facilitate continuous improvement and maintain quality
1999 - 1999(Harlow - England- Development pharmaceutique)
1.Responsible for the development of new chemical entities formulation using wet and dry granulation and particles and tablet coating technologies
2.Manufacture of clinical batch
3.Work in c-GMP environment