MSAT Bioprocess Engineer mRNA

MSAT Bioprocess Engineer mRNA

Lonza

Geleen, Netherlands

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.

Apply Now