Msat Microbial Process Expert Usp or Dsp

Vor 7 Tagen

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday, 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.

Lonza has a strong track record in the microbial manufacturing of Biologics from early clinical to large scale commercial supplies. Our Lonza Microbial Operation Organization is recognized as a complete service provider from strain development through large scale manufacturing in microbial fermentation of biopharmaceuticals.

Key responsibilities:

- Act as the interface between the process donor (customer, process development), the capital investment project team and manufacturing for all process related queries
- Provide technological and process support to the capital investment project team in the design, specification and selection of the equipment of the new built facility
- Ensure process scalability and manufacturability for USP (fermentation, primary recovery) or DSP (chromatography, ultrafiltration) and end fill steps
- Perform GMP risk assessments and prepare all procedural documents required prior to commencing GMP activities, including selection and ordering of materials
- Provide process support to manufacturing during the qualification of the new built facility and lead process validation activities with focus on validation batches at scale (on the process side)
- By positive project evolution, responsible for the execution of the assigned product/ project in the best possible time, quality and cost as well as in compliance with the relevant laws, regulations and guidelines regarding safety, quality, regulation, hygiene and the environment from a MSAT point of view

Key requirements:

- PhD (preferred) or Master in Life Sciences (Biotechnology, Biochemical Engineering, Chemical Engineering or related field)
- Significant professional experience in Process Expert or similar position in clinical and/ or commercial biomanufacturing, preferably in Microbial Manufacturing
- cGMP experience and deep understanding of Bioprocess technology
- CQV and/or experience in the commissioning and qualification of a new facility is a plus
- Excellent communication skills for interaction with customers and within the project organization
- Fluency in English, German would be an advantage
- High attention to detail and very good problem-solving skills
- Strong organizational and project management skills

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.

**Reference: R49274**:

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