Wat ga je doen
The Fill & Finish Process Development Specialist is one of the key contributors in the process development activities from technology transfer to the manufacturing site until manufacturing of process verification/validation batches to be introduced in the global market. You will be part of a dynamic and accomplished team and are responsible for:
• the setup, reporting and timely execution of process development, characterization and validation activities. These activities can be done in-house or externally.
• Managing and challenging the various stages of the project.
• establishing and maintaining a trustful and professional relationship with the different stakeholders from other departments within the company as well as with external partners.
• the technical content of the registration dossier, by guaranteeing availability of source documentation and raw data.
• leading and/or participating in specialized committees, as appropriate to ensure continuous improvement on departmental and project level.
Wat vragen wij
For the position as Fill & Finish Process Development Specialist you have a MSc/BSc degree in pharmaceutical sciences or other relevant discipline (pharmacy, (bio)chemistry or other life sciences). Furthermore:
- You have at least 5 years of experience in vaccine and/or large molecule process development
- GMP drug product manufacturing is required
- Experience with technology transfers and outsourcing is concidered an advantage
- You have a strong work ethic and able to communicate, analyze problems and show initiative.
- You are able to travel and go/stay abroad for up to 1 week
Wat hebben we te bieden
- A contract for 12 months at CheckMark, with the possibility of an extension
- Salary indication from €3627 gross per month based on fulltime
- Full-time position (40 hours/week)
Waar ga je aan de slag
Our client is a large pharmaceutical company focused on bringing innovation to global health.