Analytical Development and CMC Expert: Special Projects
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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have 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 Analytical Development and CMC Expert: Special Projects.
- Represent DPS as analytical development and QC subject matter expert as well as full-time member of the non-platform molecule innovation team
- Define, document and execute new processes and methods (high-throughput, UPLC, alternative technologies) to enable short project timelines for drug substance and drug product
- Ensure new processes developed by the innovation team are scalable, cost-effective and market competitive by using design thinking and other innovation concepts
- Communicate and align new development and business processes created by the team according to requirements of DPS
- Design analytical strategy for chromatographic and electrophoretic testing for non-platform biologics for testing of drug substance and drug product
- Stay up-to-date on CMC strategy, pharmacopeia as well as issues/trends in the industry and analytical method development of biologics (e.g. non-mAbs, cytokines, fusion proteins)
- Manage analytical development and method evaluation as well as technologies to support formulation development, drug product testing (GMP and non-GMP, specifically including HPLC and CE purity methods) and customer non-platform projects
- PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Substantial work experience in analytical development and/or QC, preferably with cGMP experience
- Good working knowledge in all relevant analytical techniques and ability to interpret complex analytical data
- Experience with parenteral dosage forms and protein analytics
- Capability to work independently and in a team environment
- Excellent communication, supervisory, reporting and scientific skills
- Fluency in written and spoken English
- Knowledge of analytical life cycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired
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.