QC Specialist DPS Growth Project 80-100% (m/f/d)
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 join us by applying for the position as QC Scientist for a new sterile Drug product facility to support quality control and manufacturing related project activities..
Key responsibilities:
Provide expertise and ensure support for adequate cGMP lab processes and respective infrastructure for the QC laboratory in frame of project ramp-up for commercial Drug Products.
Contribution to evaluation of analytical methods and corresponding instrumentation including automation technologies for DPS commercial QC
Authoring of cGMP documents e.g. procedures (SOPs)
Initiate, author and review quality records (Deviations, Change requests, Investigations etc.) as required.
Support the lab team and ensure timely progress of sample testing
Contribute with expertise in audits and inspections
Trainer for analytical instruments and corresponding test methods where applicable
Oversight of the qualified state of assigned instruments for DPS QC in close alignment with internal and external partners following current best practices and regulations.
Key requirements:
Apprenticeship or academic degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
Significant working experience in pharmaceutical industries and cGMP controlled environment
Experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc. as well as understanding of current requirements related to instrument qualification and corresponding documentation
Thorough experience in corresponding Laboratory IT/OT (LIMS / Tiamo / Empower / etc.)
Fluency in written and spoken English, German is an asset
Capability to work independently and in a dynamic & fast-pacing project environment
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.