Senior Scientist - Method Development & Validation (MDV)
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.
Reporting to the Group Leader, the remit of this role is to provide purity and impurity methods in support of process and product development and manufacture for antibodies and other recombinant proteins being manufactured by Lonza Biologics
- To perform laboratory work, collate, analyse and interpret data to communicate progress and escalate challenges to Line Manager, project teams and customers as appropriate.
- To lead multiple studies (transfer/development and or validation for a range of analytical methods with a high level of complexity) /project simultaneously and ensure work executed appropriately.
- To lead trouble shooting/out of specification investigations as required
- Review and approve GMP (Good Manufacturing Practice) documentation e.g. SOPs, protocols and reports, regulatory as required.
- Deliver training; promote good scientific practice and process improvements in line with regulatory requirements. To coach and/or mentor junior scientists/technologists.
- Evaluating and driving new innovations to the Method validation and Development department.
- May have System owner, Area or Platform owner responsibilities.
- PhD/BSc in relevant scientific discipline or relevant previous experience
- Advanced knowledge of analytical methods used to analyse the purity, identity and impurities of protein products manufactured by mammalian cell culture processes
- Product purity and identity methods (eg icIEF, CE SDS, SE-HPLC, IEX, RP-HPLC, HIC)
- Manufacturing process-related impurity methods (eg DNA qPCR, HCP ELISA and Protein A ELISA)
- Expert knowledge of analytical method development
- Advanced knowledge of analytical method validation
- Advanced knowledge of glycoprotein biochemistry
- Advanced experience of the interpretation of analytical data from protein products generated throughout the mammalian cell culture manufacturing process
- Advanced knowledge of the relevant analytical regulatory requirements
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