Lead Scientist Commercial Qc 80-100%
Vor 7 Tagen
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 and commercial 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.
- Scientific and GMP experience, commercial and financial acumen
- Strong analytical and problemsolving 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
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
- Reference: R60168
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