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MSAT Bioprocess Engineer mRNA

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Geleen, Limburg, Nederland Lonza Voltijd

Job Summary

Lonza, a global leader in life sciences, is seeking a highly skilled Bioprocess Engineer to join our Manufacturing Science and Technology (MSAT) Team. As a key member of our team, you will be responsible for ensuring process scalability and manufacturability, coordinating major deviations and process adaptations, and driving continuous improvement of our manufacturing processes.

Key Responsibilities:

  • Transfer mRNA-LNP process into GMP production and collaborate with cross-functional teams to ensure timely delivery of technology transfer activities.
  • Supervise and report on process integration during and after production campaigns.
  • Act as a technical Subject Matter Expert in mRNA-LNP processes within the MSAT Team and for various project teams.
  • Provide technical support for process validation, GMP, and deviation investigations, CAPAs, and change controls.
  • Review and author technology transfer documents, including Fit/Gap analysis, FMEA, PFD/BFD, and MBRs.
  • Manage and analyze data of various operational parameters.
  • Recommend improvements for MSAT and MFG practices and procedures.

Requirements:

  • Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related field; PhD or Master's degree preferred.
  • Substantial experience with biologics process development, MSAT, or manufacturing.
  • Knowledge of CMC regulations and international guidelines, including FDA, EMA, PMDA, and NMPA.
  • Experience with mRNA-LNP process and/or other protein purification processes, scale-up, chromatography operation, UF/DF, TFF, aseptic filling, and fill & finish.

About Lonza

Lonza is a global leader in life sciences, operating across three continents. We value talented people working together to devise innovative solutions that help businesses improve lives. We offer a dynamic work environment where our people can own their careers, develop new ideas, and make a meaningful difference.