MSAT Bioprocess Engineer mRNA

7 dagen geleden

Geleen, Limburg, Nederland Lonza Voltijd

Join Lonza's Team of Experts

At Lonza, we are seeking a highly skilled Manufacturing Science and Technology (MSAT) Bioprocess Engineer to join our team. As a member of our MSAT Team, you will be responsible for ensuring process scalability and manufacturability, collaborating with cross-functional teams, and coordinating major deviations and process adaptations.

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.

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.

At Lonza, we are committed to improving lives all around the world. We offer a dynamic and challenging work environment where you can grow and develop your skills. If you are passionate about life sciences and want to make a meaningful difference, we encourage you to apply for this exciting opportunity.

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