MSAT Scientist

• Drives completion of process assessment and validation activities as per agreed timeline in close collaboration with internal and external parties.
• Executes proper assessment on all process related areas including the process, APS, facility, equipment, and materials from a GMP point of view, identifying risks and suggesting appropriate mitigation strategies.
• Drives process performance data trending during product lifecycle, assessing process performance and providing suggestions for process improvement following new product introduction principles.
• Actively participates in troubleshooting and serves as investigation lead for process impacting deviations and investigations.
• Provides technical guidance on change controls and how they might impact customer processes.
• Provides supervision and technical guidance to the junior members of the team.

What they ask

• Extensive knowledge in the field of process validation, cell and gene therapy and applicable technologies, GMP and aseptic manufacturing, and risk mitigation.
• Solid experience in interacting and collaborating with clients and internal parties, including professional communication and transparency.
• Experience in training junior team members on their daily tasks.
• Solid knowledge and adherence to ATMP specific regulations.
• Strong communication skills and the ability to deal with various stakeholders.