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 MSAT Expert where you will be responsible for successful drug product and manufacturing process transfers as well as implementation at the manufacturing site. Join us to lead projects to improve and expand manufacturing capabilities across our DPS network.
Key Responsibilities:
Participate in GMP risk analysis for the manufacturing processes and Contamination Control Strategy of the facility
Contribute to the development and implementation of standardized MSAT procedures and processes (e.g. qualification standard and strategy, single use system…)
Partake in cross-functional teams as MSAT Expert tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale
Support new product introduction by evaluating/developing ‘fit for purpose’ processes
Take care of process monitoring and process control strategy as well as complex data analysis
Own concepts on site or across the DPS network continuously improving in quality and efficiency in compliance to cGMPs, SOPs, EHS and applicable guidelines
Lead Performance qualification activities for new equipment, filling line or a facility and support Process Performance Qualification of Biologics License Application projects
Lead complex product and process related investigations and deviations including complaints actions and resolve technical challenges within area of expertise.
Maintain processes at Inspection readiness level and to provide the necessary support in any internal or external audits as well as in Back/Front office or in facility tours
Key requirements:
University degree preferably in Biotechnology, Chemistry, Pharmacy, Engineering, Pharmaceutical Technology or equivalent scientific degree / equivalent experience
Working experience in aseptic drug product manufacturing (clinical product and/or commercial product)
Proven process and regulatory understanding in Sterile Manufacturing, cGMP and writing SOPs
IT knowledge in SAP or MES is an asset
Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor
Experience in international inspection / audit is an asset
Fluency in English, German is an asset
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.