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MSAT Specialist USP 80
Vor 6 Tagen
Switzerland, Stein
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.
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and apply for the position as an MSAT Specialist where you will be Responsible for the successful drug product and manufacturing process transfer and implementation at the manufacturing site. Lead projects to improve or expand the manufacturing capabilities. Continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs, SHE and applicable guidelines
Key Responsibilities:
- Enable manufacturing of drug products by ensuring ‘fit for purpose’ processes. Apply formal processes and tools to manage the transfer of information, process related risks and change control.
- Proactively anticipates, evaluates and resolves technical challenges within area of expertise.
- Takes care of process monitoring and process control strategy as well as data analysis
- Lead small to medium sized projects to improve or expand the manufacturing capabilities at the
- site and within DPS (Drug Product Services)
- Lead product and process related investigations and deviations including complaints actions.
- Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
- Maintain their processes at Inspection readiness level and to provide the necessary support in any internal or external audit. Support in Back/Front office or in facility tour
Key requirements:
MSc. in Pharmaceutical Technology, Pharmacy, Biochemistry or equivalent scientific degree.
Desirable PhD in a relevant field.
Fluency in English, German is an asset
1-2 years industry experience in aseptic drug product manufacturing (clinical product and/or commercial product) is desirable
Proven process understanding (Pharma, GMP, Regulatory aspects, Good documentation practice)
Process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
Familiarity with GMP requirements
Good communication skills and interaction with a variety of interfaces within the organization and with customers
Strong team orientation
Proven IT knowledge, knowledge in Microsoft office tools
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: R57453Apply Switzerland, Stein-
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