Our client is a 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 Specialist you will be responsible for the technology transfer to the manufacturing site of the process validation batches to be introduced in the market.
- Setup, reporting and execution of process development, characterization and validation activities.
- Project management: preparing project plans; reporting periodically and escalating; judging when and what (external) knowledge should be sourced.
- Stakeholder management (other departments, CMOs).
- Manage the technical content of the registration dossier.
- Leading and/or participating in specialized committees, as appropriate to ensure continuous improvement.
- MSc in pharmaceutical sciences or related discipline ((bio)chemistry, life sciences, engineering).
- 2-5 years of experience in vaccines and/or large molecule process development and GMP product manufacturing.
- Experience with tech transfers and outsourcing is an advantage.
- Excellent communication skills in English. Dutch is a big plus.