MSAT - Process Expert Mammalian Cell Culture DSP, Ibex

Lonza Group Ltd.; Oberwallis; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Lonza Visp site in Switzerland seeks experienced Process Experts in Ibex® Solutions for mammalian large-scale manufacturing (up to 20,000 L). You will own the successful scale up, supervision and optimization of mammalian processes, including technology transfers and cross-functional collaboration.

Qualifications include a Bachelor/Master’s (PhD preferred) in Biotechnology or Chemical Engineering with 5+ years in biopharma manufacturing or process development, and fluency in English and German.

Qualifikationen

• Requires more than 5 years in biopharma manufacturing or process development.
• GMP knowledge and deep understanding of bioprocess technology.
• Fluency in English and German.

Aufgaben

• Lead technology transfers and scale-up of mammalian processes.
• Oversee process design, up-scaling, and implementation at manufacturing scale.
• Coordinate between process development and operations; manage information transfer and risks.
• Deliver input for block-flow diagrams, media/buffer lists and validation-related content.
• Mentor staff and drive continuous improvement in MSAT initiatives.

Kenntnisse

Leadership

Communication

Teamwork

Project coordination

Ausbildung

Bachelor or Master’s degree in Biotechnology or Chemical Engineering

PhD preferred

Jobbeschreibung

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for experienced Process Experts and Senior Process Experts in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. We have opportunities 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.

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.