GEX
I worked on a number of different pharmaceutical dosage forms defining both the commercial formulation and its process, from early development to full scale production batches. I have experience leading cross-functional and international teams.
Key achievements:
- Successful project management: bringing complex multisite projects from early stage development to global submissions.
- Global development and implementation of Quality by Design (QbD) at Ferring.
Skills:
- Profound knowledge of all aspects of QbD from development to Process Validation and Continued Process Verification.
- Certified Six Sigma and DFSS (Design For Six Sigma) Black Belt.
- Drug delivery technologies (medical devices) and platform expertise for peptide and protein drugs.
- Scale-up and tech transfer.
Mes compétences :
Formulation
QbD
Tech Transfer
Global submissions
