MSAT – Process Expert Mammalian Cell Culture DSP, Ibex

Key responsibilities:

• Leading cross functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals.
• Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability.
• Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control
• Working as MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for the specific processes (block-flow diagrams, media and buffer lists, critical parameter lists)
• Responsible for implementing the manufacturing process in the plant.
• Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance.
• Ensuring timely compilation of process related deviations, change requests and campaign reports
• Compiling CMC sections in filing documents and technical content of validation reports
• Contributing to the development and implementation of standardized MSAT procedures and processes.
• Responsible for continuous improvement of process performance
• Supervising tasks in the area of local and global MSAT initiatives or leading major task forces or troubleshooting teams.
• Evaluating and driving innovative trends within the respective area of expertise
• Acting as a mentor for scientific and production staff in different fields of expertise.
• Performing process specific trainings for production staff.
• Responsible for the resolution of process issues that may arise during manufacturing, considering all regulatory requirements
• Responsible for execution of GMP risk analysis for the manufacturing processes.

Key requirements:

• Bachelor / Master's degree, PhD preferred
• Preferred area of study: Biotechnology, chemical engineering or related disciplines
• More than 5 years of experience in the area of biopharma manufacturing and / or process development preferable in the area of Mammalian Manufacturing
• GMP and deep understanding of bioprocess technology
• Fluency in English and German
• Strong leadership skills
• Very good communication skills and interaction with all kinds of interfaces within customers and the project organisation
• Strong team orientation
• Structured, focused and well-organized working attitude
• Open-minded for new ideas and suggestions
• Agile, highly motivated and dynamic drive
• Solution-oriented

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.