Manufacturing Science & Technology Expert- Drug Product
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.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As a MSAT (Manufacturing Science & Technology) expert, you are responsible for the successful process implementation and transfer, supervision and optimization of Drug Product processes in the new sterile Drug Product Manufacturing facility in GZB.
- 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.
- 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 cross-functional teams as a MSAT expert tasked with technology transfers (process implementation and transfer) 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.
- Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control.
- Actively communicates, presents data, and collaborates with the customer via both face-to-face meeting and teleconferences.
- Contribute to the preparation of the 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).
- 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.
- 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.
- Bachelor or above, majoring in Pharmaceutical Technology, Chemistry, Process Engineering or equivalent scientific degree.
- Extensive working experience in Sterile Manufacturing on the shopfloor and/or MSAT, QC/QA related area;
- 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, 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.