Senior Manufacturing Fill & Finish Process specialist
They are one of the biggest and most respected health care companies in the world. This company focuses on the development of novel therapeutics and vaccines to treat, cure and prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern such as polio and Ebola.
The Fill & Finish Process (FFP) team is responsible for the external manufacturing of drug product. As manufacturing FFP specialist you operate at the technical interface between the project teams and the external drug product manufacturing sites.
- Proper and timely execution of drug product manufacturing activities;
- Review of the (master and executed) batch documentation prepared by the manufacturing site and bringing it to the required quality level;
- Being physically present during drug product manufacturing (Person in Plant, PiP), resolving issues on the spot and guiding corrective measures if required;
- Establishing and maintaining a trustful and professional relationship with the external drug product manufacturing sites;
- Participating in the multidisciplinary project teams, ensuring alignment with project needs;
- Identifying and implementing improvements in the way of working;
- Being all-round expert in quality, regulatory, technical and business aspects of external manufacturing.
- Minimum BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry)
- At least 8 years experience in large molecule GMP drug product manufacturing, preferably vaccine related
- Must have Project Management experience
- Experience with process development, project management and outsourcing is an advantage.
- Change management experience
- Affinity with coaching more junior team members and share knowledge
- Structured work ethic