MSAT Bioprocess Engineer mRNA

1 week geleden

Geleen, Limburg, Nederland Lonza Voltijd

At Lonza, we are seeking a talented Bioprocess Engineer to join our Manufacturing Science and Technology (MSAT) Team. As a member of this team, you will be responsible for ensuring process scalability and manufacturability, collaborating with cross-functional teams to deliver technology transfer activities on time, and providing technical support to process validation, GMP, and deviation investigations.

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 believe that our people are our greatest asset. We offer a dynamic and challenging work environment that allows our employees to grow and develop their skills. If you are a motivated and experienced Bioprocess Engineer looking for a new challenge, we encourage you to apply for this exciting opportunity.

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