MSAT – Process Expert Mammalian Cell Culture DSP, Ibex

The site in Visp, Switzerland is growing and for the Biologics organization, experienced Process Experts and Senior Process Experts are sought for Ibex® Solutions, a recently launched unique biological manufacturing and development concept. Opportunities are available in both USP and DSP in Drug Substance for mammalian large-scale manufacturing (up to 20,000L). As a process owner, you are responsible for the successful scale up, supervision and optimization of mammalian processes.

• Lead cross-functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale.
• Manage the whole lifecycle of assigned projects from planning, coordination, implementation, control, to project completion aligned with project management goals.
• Act as the interface between the process donor (customer, process development) and operations.
• Ensure process scalability and manufacturability.
• Secure success during technology transfer by applying formal processes and tools to manage the transfer of information, process-related risks and change control.
• Work as MSAT process expert in capital investment projects for building and commissioning of manufacturing units.
• Deliver all input required for specific processes (block-flow diagrams, media and buffer lists, critical parameter lists).
• Implement the manufacturing process in the plant.
• Interact directly with customers during tech transfer, campaign preparation, execution and closure, including daily reporting of batch status and performance.
• Ensure timely compilation of process-related deviations, change requests and campaign reports.
• Compile CMC sections in filing documents and technical content of validation reports.
• Contribute to the development and implementation of standardized MSAT procedures and processes.
• Responsible for continuous improvement of process performance.
• Supervise tasks in the area of local and global MSAT initiatives or lead major task forces or troubleshooting teams.
• Evaluate and drive innovative trends within the respective area of expertise.
• Act as a mentor for scientific and production staff in different fields of expertise.
• Perform process-specific trainings for production staff.
• Resolve process issues that may arise during manufacturing, considering all regulatory requirements.
• Execute GMP risk analysis for the manufacturing processes.