Msat Lead

Vor 6 Tagen

Visp, Schweiz Lonza Vollzeit

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.

**Key responsibilities**:

- Working as MSAT expert in Capital investment projects for building and commissioning of the manufacturing units.
- Responsible for implementing the manufacturing process in the plant, as received from DP process development.
- Participate in GMP risk analysis for the manufacturing processes and Contamination Control Strategy of the facility.
- Act as the process acceptor into DP manufacturing from internal formulation and process development as well as drop-ins from other clinical facilities and customers. Participating in teams of many functions as a MSAT Expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale.
- Lead the preparation of the Qualification / Validation Master Plan. Prepare and perform Qualification and Validation activities in compliance with cGMP regulations and specification requirements.
- Write, Review and Execution of Qualification / Validation protocols (OQ, PQ, APS). Review and approval of third party generated protocols and reports. Provide regular updates on qualification activities and performance. Leading/participate in change controls and deviations.
- Contributing to the development and implementation of standardized MSAT procedures and processes (e.g. qualification standard and strategy, single use system...).
- Responsible for continuous improvement of process performance and product quality. Proactively anticipates, evaluates and resolves technical challenges within area of expertise.
- Acting as a support for scientific and production staff in different fields of expertise. Acts a link between Drug Product Services, mainly formulation, process development and manufacturing, and QC. Takes care of process monitoring and process control strategy as well as complex data analysis.

**Key requirements**:

- BSc or MSc/ PhD or equivalent experience in Pharmaceutical Technology, Chemistry, Process Engineering or equivalent scientific degree.
- At least 5-10 years’ experience in Sterile Manufacturing on the shopfloor and/or MSAT, QC/QA.
- Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects).
- Very good communication skills and interaction with all kinds of interfaces within customers and the project organization; strong team orientation and collaboration across groups and Lonza sites.
- Structured, passionate, and methodical work approach; receptive to new ideas and suggestions; adaptable, motivated, and driven; passionate about finding solutions

Inclusion is one of Lonza’s four core values, alongside integrity, innovation and initiative. We understand the value of our differences and the benefits they bring to our company, community and culture. We also recognize the value of every person’s contribution, regardless of characteristics, preferences and beliefs - including race, color, ethnicity, sexual orientation, gender identity and religion.

We want everyone who works at Lonza to take pride in their role, take ownership of their responsibilities and drive their career forward. If you achieve these goals, you will be rewarded for your contribution. Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. Depending on your location, these benefits could include family allowances, childcare support, discounts for local businesses and attractions, travel allowances and subsidized meals.

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: R62902

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