Characterisation Scientist (All Levels)
United Kingdom, Slough
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
As a member of the Characterisation team, you will lead, direct and manage analytical comparability and characterisation work/study programs for pre-clinical and clinical phase biopharmaceutical products. Ensuring analytical studies meet the required quality standards, data has been correctly interpreted and the analytical methods used are fit for purpose. You will also be responsible for the flawless planning and execution of analytical testing on therapeutic proteins to support product characterization and biocomparability studies for our customers, contributing to their drug development lifecycle and in getting lifesaving medicines to market.
- Effective planning and performing of analytical work, preparation of study protocols and reports and review of analytical data ensuring scientific objectives and timelines are met
- Preparation of GMP documentation e.g. SOPs and raise/complete regulatory records as required
- Working as part of a multi-disciplinary scientific technical team for commercial and/or innovation projects as required, collaborating with scientists in other Lonza BU as applicable
- Identify and drive departmental improvement projects
- Ensuing studies performed meet the required quality standards
- Maintaining a high level of scientific expertise and keeping up to date with current technical and regulatory expectations
- Actively supports the training and coaching of junior scientists
- Prepare and deliver training; both classroom sessions and practical demonstrations
- Degree in Chemistry, Biochemistry or Life Science
- Familiarity with methods and instruments used for protein characterisation such as LC-MS (peptide mapping, intact mass analysis and oligosaccharide profiling), icIEF, CE-SDS, HPLC (SEC, RP, HIC, IEX, HILIC) and SEC-MALS
- Expert appreciation of running Mass Specs and how to use the data
- Experience of Complex proteins – Complex antibodies – Complex Molecules
- Understanding of protein structure, post translational modifications, degradation pathways for recombinant proteins
- Understanding of phase appropriate regulatory and quality expectations for clinical phase analytical characterisation and comparability studies
- Understanding of analytical control strategies applied to biopharmaceutical products
- Putting together Packages of Work and Designing of Experiments
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.