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.
My client is looking for two different types of profile for this position:
1) Tech Transfer Specialist - responsible for product manufacturing tech. transfer;
2) Regulatory Submission Writing Specialist - responsible for providing technical content of the registration dossier
- Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
- Setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally
- Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level.
Requirements- BSc, MSc or PhD. in the life sciences
- Proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers
- Life cycle process validation; regulatory submission writing; technology transfer; process improvements.
Do you have any of those skills and you want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga at +31 (0) 20 658 98 01 or firstname.lastname@example.org.