Msat Expert Drug Product
Vor 2 Tagen
Switzerland, SteinToday, 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.
**Key responsibilities**:
- Work as MSAT expert on capital investment projects constructing and commissioning manufacturing units
- Implement manufacturing processes in the plant and participate in GMP risk analysis of those
- Act as Drug Product manufacturing process approver for external and internal customers as well as lead change controls and deviations
- Communicate, negotiate and collaborate with customers as well as handle drop-ins from clinical facilities and clients
- Lead preparation, review and approval of validation master plan and perform Qualification and Validation activities in compliance with cGMP regulations and specification requirements
- Write, review, approve and execute Qualification / Validation protocols (OQ, PQ) as well as third party generated protocols and reports
- Contribute to the development and implementation of standardized MSAT procedures and processes as member / lead of cross functional teams
- Act as mentor and link for scientific and production staff in different fields of expertise between Drug Product Services (DPS Basel), Quality Control and Visp Drug Product manufacturing
- Take care of process monitoring and process control strategy as well as complex data analysis
**Key requirements**:
- University degree in Pharmaceutical Technology, Chemistry, Process Engineering or equivalent
- Significant work experience and proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
- Very good communication and interaction skills with various interfaces among customers and the project organization
- Experience in leading cross-functional project teams
- Structured, focused and well-organized working attitude
- Fluency in English and German
- Green belt certification preferred
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: R47907**:
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