Lead Scientist Commercial QC 80-100%
vor 1 Monat
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 our site in Basel, we are looking for Lead Scientist Commercial QC .
Key responsibilities:
Review analytical testing documentation according to SOPs for clinical and commercial samples.
Support implementation, validation, transfer analyses to perform release and stability testing under GMP, following applicable SOP’s and all current documentation practices.
Contribute to the establishment of DPS Commercial QC infrastructure and services for e.g. parenteral clinical andcommercial Drug Substance and Drug Products under GMP.
Support QC release decision, including LIMS
Support Empower 3.x
Support to maintain the qualified state of analytical instruments for DPS QC in close alignment with current best practices and regulations
Raise and progress laboratory investigations and quality events (e.g. OOS, SST, deviations, CAPA, tasks)
Contribute to the evaluation and establishment of analytical methods and technologies as required
Ensure safety and health protection by following lab and safety instructions and all cGMP regulations.
Key requirements:
Degree in life sciences or management (Bachelor, Master, Ph.D., MBA or similar)
Scientific and GMP experience, commercial and financial acumen
Strong analytical and problem-solving skills
Substantial experience in QC, project management, QA or similar
Results oriented and able to prioritize workload to meet timelines
Knowledge of pharmaceutical regulatory landscape (e.g. ICH guidelines, PIC/s, US FDA, PMDA, EMA)
Excellent communication skills, command of English, academic writing
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.
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