Internship MSAT Material Management / MSAT Process Expert

Support activities related to material management in microbial cGMP manufacturing processes. Support mitigation actions in material quality issues. Support design and qualification of single use assemblies. Coordinate inputs from multiple stakeholders (MSAT, QA, QC, Production, Supply Chain) during document preparation and review. Monitor progress of activities and identify potential delays or roadblocks. Escalate issues and risks in a timely manner to the responsible MSAT process expert lead. Support data review, trending and analysis activities related to material management. Support MSAT Process Expert core activities in the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals. Support the resolution of process issues that may arise during manufacturing, considering all regulatory requirements. Support the execution of GMP risk analysis for the manufacturing processes. Support timely compilation of process related deviations and change requests (related to material management and cGMP manufacturing processes). Support continuous improvement projects.

MSAT Microbial provides end-to-end technical expertise across the microbial manufacturing lifecycle, acting as the key link between process knowledge, manufacturing execution and product quality. The team serves as process experts for microbial upstream and downstream processes, supporting process understanding, troubleshooting, and continuous improvement during clinical and commercial manufacturing. In parallel, the MSAT expert is providing support to project teams in regard to initial raw material selection, design and qualification of single use assemblies, support during material quality issues and shortages. Through close collaboration with Manufacturing, Quality and other cross-functional partners, MSAT Microbial ensures robust, compliant and scalable processes, supporting safe, reliable and efficient drug substance supply.

• Bachelor’s or Master’s degree in Biotechnology, Chemistry, Chemical, Biochemical Engineering, Pharmacy or a related scientific or technical discipline

• Strong interest in microbial manufacturing processes and process lifecycle management

• Basic understanding of bioprocess fundamentals, such as: microbial upstream and/or downstream processes and process parameters and their impact on product quality

• High attention to detail and interest in technical documentation and data integrity

• Strong interest in GMP environments and regulated manufacturing

• Good organizational and planning skills, with the ability to manage multiple tasks and timelines

• Ability to work effectively in cross-functional teams, interacting with Manufacturing, Quality and Quality Control

• Structured, analytical mindset with problem-solving orientation

• Good knowledge of English, both written and spoken