Process Expert MSAT - Mammalian Large-Scale

Process Expert MSAT - Mammalian Large-Scale

Lonza

Visp, Switzerland

Key responsibilities:

• Leading multi-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.
• Acting as the interface between the process donor (customer, process development) and operations, ensuring 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.
• Resolving process issues that may arise during manufacturing, considering all regulatory requirements.
• Completing GMP risk analysis for the manufacturing processes.
• Expert in MSAT process for capital projects, providing necessary inputs for manufacturing unit construction.
• 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.
• Continuously improving 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 training for production staff.

Key requirements:

• Bachelor’s/Master’s degree or equivalent experience, PhD preferred.
• Preferred area of study: Biotechnology, chemical engineering, or related fields.
• More than 5 years of experience in biopharma manufacturing and/or process development, preferably in Mammalian Manufacturing.
• GMP and deep understanding of bioprocess technology.
• Proficiency in English and German would be advantageous.
• Strong leadership skills and a proven ability to lead teams.
• Outstanding communication skills and the ability to interact with various interfaces within customers and the project organization.
• Strong team orientation with a collaborative approach.
• Structured, focused, and well-organized working attitude.
• Open-minded to new ideas and suggestions.
• Agile, highly motivated, and dynamic drive.
• Passionate about solving challenges with a positive outlook.

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