mRNA Bioprocess Engineering Specialist

5 dagen geleden

Geleen, Limburg, Nederland Lonza Voltijd

Company Overview: Lonza is a prominent global entity in the life sciences sector, operating across multiple continents. Our approach to science is grounded in collaboration, where talented individuals come together to generate innovative solutions that enhance business capabilities and improve lives.

Position Summary: We are currently seeking a Manufacturing Science and Technology (MSAT) Bioprocess Engineer specializing in mRNA at our facility. In this role, you will collaborate closely with clients and development scientists to ensure the scalability and manufacturability of processes. You will also oversee major deviations and process adaptations while driving continuous improvements in manufacturing operations.

Key Responsibilities:

  • Facilitate the successful transition of mRNA-LNP processes into GMP production, working alongside cross-functional teams to ensure timely execution of technology transfer activities.
  • Oversee process integration, supervision, and reporting throughout production campaigns.
  • Serve as a technical Subject Matter Expert in mRNA-LNP processes within the MSAT Team and various project teams.
  • Provide technical guidance for process validation, GMP compliance, execution of new processes, and investigation of deviations, CAPAs, and necessary change controls.
  • Conduct thorough reviews of client and development processes to create technology transfer documentation, including Fit/Gap analyses and FMEAs, and author/review PFD/BFD and MBRs.
  • Manage and analyze data related to various operational parameters, recommending enhancements for MSAT and manufacturing practices.

Key Requirements:

  • A Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related field is required; a Master's or PhD is preferred.
  • Extensive experience in biologics process development, MSAT, or manufacturing is essential.
  • Strong knowledge of CMC regulations and international guidelines, including FDA, EMA, PMDA, and NMPA.
  • Familiarity with mRNA-LNP processes and/or other protein purification methods, scale-up, chromatography operations, UF/DF, TFF, aseptic filling, and fill & finish processes.

Conclusion: At Lonza, we recognize the significant impact our products and services have on millions of lives. We believe that achieving our business goals ethically is paramount. Our team is dedicated to solving complex challenges and fostering innovation in life sciences, providing the opportunity to make a meaningful difference in the world.

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