Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
As a Fill/Finish Process Development Scientist you will be working within the Fill/Finish team responsible for the development of fill/finish processes and tech transfers.
- Set up, report and timely execute process development, characterization and validation activities, which can be done in-house or externally
- Provide input to define the technical content of the registration dossier, by guaranteeing of source documentation and data
- Stakeholder management of internal partners (Process Development, Regulatory Affairs, Drug Development, Manufacturing...) and external (CMOs)
- Lead and participate in specialized committees to ensure continuous improvement.
- MSc or PhD in biopharmaceutical sciences, biotechnology or similar.
- 5 to 10 years of experience in a proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including tech transfers.
- Experience with life cycle process validation, process validation, regulatory submission writing, tech transfer or process improvements.
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.