MSAT Bioprocess Engineer mRNA
3 dagen geleden
Lonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that help businesses improve people's lives. In return, we empower our employees to own their careers, allowing them to genuinely make a positive impact on the world.
We are seeking a Manufacturing Science and Technology (MSAT) Bioprocess Engineer to join our team in the Netherlands. As a member of the MSAT Team, you will be in direct contact with clients and development scientists, ensuring process scalability and manufacturability. You will also be responsible for coordinating major deviations and process adaptations, as well as driving continuous improvement of 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 project teams.
- Provide technical support for process validation, GMP, and deviation investigations.
- Review and author technology transfer documents, including Fit/Gap analysis, FMEA, and campaign summary reports.
- Manage and analyze operational data.
- Recommend improvements for MSAT and MFG practices and procedures.
- Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related field; PhD or Master's degree preferred.
- Substantial experience in biologics process development, MSAT, or manufacturing.
- Knowledge of CMC regulations and international guidelines, including FDA and EMA.
- Experience with mRNA-LNP process and/or other protein purification processes, scale-up, chromatography operation, UF/DF, TFF, aseptic filling, and fill & finish.
At Lonza, we respect and protect our people and the environment. Our success is not just about achieving business results, but also about doing so ethically. We offer a challenging and creative work environment where you can make a meaningful difference in people's lives.
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