Scientist, Clinical Quality Control
vor 6 Monaten
Switzerland, BaselLaboratory Scientist
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.
Our Drug Product Services department will provide best-in-class services for parenteral dosage forms for several drug classes, and provide a one-stop-shop for all clinical outsourcing requirements.
As a Laboratory Scientist at Lonza Drug Product Services, Quality Control, you can be at the heart of it, right from the start. You will get a first overview of processes under GxP in the pharmaceutical industry and get in touch with novel analytical techniques for biomolecules.
**Key responsibilities**:
- Carry-out Physico-Chemical analytical tests according to cGMP standards on drug products in clinical development or commercial phase (including HPLC and CE purity methods, charge heterogeneity by IEC/iCE, content by UV, identity (pepmap), color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visible particles, sub-visible particles and related DP analytics)
- Follow applicable SOPs and current documentation practices
- Review and approve phys-chem analytical test reports as required, following applicable SOPs and all current documentation practices
- Ensure proper maintenance of equipment as well as safety and health protection following cGMP regulations, lab and safety instructions
- Support installation and qualification of new instruments, ensure proper maintenance of equipment for DPS Physico-Chemical Quality Control in close alignment with current best practices and regulations
- Help establish DP analytical infrastructure and services within clinical QC for biologics, small molecule and peptide parenteral products.
- Support planning of analytical method validation as well as execute and evaluate experiments based on approved protocols and guidance.
- Support cGMP regulated analytical method transfer
**Key requirements**:
- Training on the job as lab technician (FZZ, HF, CTA, BTA, PTA or BSc.)
- Working experience as a research/ technical assistant in the pharmaceutical or chemical industry, in analytical quality testing (QC)
- Experience working in a cGMP-regulated environment is advantageous.
- Strong working knowledge in relevant analytical techniques in protein/peptide analytics. Experience with laboratory specific software (e.g. Empower, LIMS-system)
- Experience in reporting, interpretation and documentation of scientific results
- Good communication and inter-personal skills; Ability to work independently in a team
- Good 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.
LI-IG1
- Reference: R60504
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