Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there is no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that is the kind of work we want to be part of.
Our Lonza site in Geleen, Netherlands, is seeking a Manufacturing Science and Technology (MSAT) Bioprocess Engineer. As a member of the MSAT Team, you will be in direct contact with clients and development scientists and responsible to ensure process scalability and manufacturability. In addition, you will be part of coordinating all process relevant major deviations and process adaptations and in charge of continuous improvement of the manufacturing processes. Become part of this exciting opportunity and apply now!
Key responsibilities:
Responsible for the successful transfer of mRNA-LNP process into GMP production and collaborate with cross-functional teams to ensure on time delivery of technology transfer activities
Be in charge for process integration, supervision and reporting during and after production campaigns
Act as a technical Subject Matter Expert in mRNA-LNP processes within the MSAT Team, as well as for the various project teams
Provide technical support to process validation, GMP, execution of the new processes and any deviation investigations, CAPAs and necessary change controls
Perform detailed review of clients and development processes to generate technology transfer documents (e.g. Fit/Gap analysis, FMEA), author/review PFD/BFD and MBRs, perform process monitoring and author campaign summary reports
Manage and analyze data of various operational parameters
Recommend improvements for MSAT and MFG practices and procedures
Key requirements:
Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology or related field; PhD or Master degree preferred
Substantial experience with biologics process development, MSAT or manufacturing
Substantial experience with CMC regulations, and international guidelines including but not limited to FDA and EMA, PMDA, NMPA
Knowledge of mRNA-LNP process and/or other protein purification processes, scale-up, chromatography operation, UF/DF, TFF, aseptic filling and fill & finish
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.