Project Lead/ Scientist Phys-chem Qc
vor 24 Stunden
Switzerland, BaselToday, 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.
**Key responsibilities**:
- In charge of successful delivery of work-packages for batch release and stability testing and support of method validations/transfers of customer clinical programs under cGMP and all applicable regulations
- Review and approve GMP phys-chem analytical tests and reports (including validation documents) as required, following applicable SOPs and all current documentation practices.
- Develop and establish analytical methods and technologies to support Phys-Chem QC and lead trouble shooting activities (specifically including HPLC, iCE and CE identity and purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection, subvisible particles and related DP analytics).
- Liaise with partner units within Lonza network to ensure the successful delivery of projects
- Establish Drug Product QC analytical infrastructure and services for biologics, small molecule and peptide parenterals for clinical and commercial products
- Supervise installation, qualification and maintenance of instruments for DP Physical Chemistry QC in close alignment with current best practices and regulations
- Evaluate and implement new methods and technologies, as required; participate and contribute to innovation, technical strategy projects and scientific publications.
**Key requirements**:
- MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Extensive working experience in Analytics or Quality Control, preferably under cGMP regulations
- Excellent working knowledge in all relevant analytical techniques
- Very good reporting and scientific skills
- Excellent ability to interpret complex analytical data
- Ability to work independently and in a team environment
- Excellent knowledge of written and spoken English
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.
**Reference: R38059**:
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