Chromatography Expert/Senior Scientist for QC Chromatography
1 week ago
We are a world-leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our mission is to "Advance Tomorrow's Medicines" and we invite you to be part of that journey.
Our Quality Control DepartmentOur Quality Control department at site Hillerød consists of approximately 230 employees divided into different support teams and four testing teams. We strive towards a OneQC team spirit where we help and support each other across teams, not only to reach our goals but also to support a high level of collaboration and possibilities for personal development.
About the JobWe are seeking a highly skilled Chromatography Expert/Senior Scientist to join our QC Chromatography team. The ideal candidate will have a master's degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar and preferably a PhD combined with experience from the pharmaceutical industry.
Key Responsibilities- You will be scientifically responsible (SME) on Chromatographic assays performed in QC Chromatography.
- Laboratory support if unexpected analytical method trends are observed.
- Author technical protocols and reports.
- Responsible for product specific qualification in relation to testing when transferring new products to our manufacturing facility.
- Daily QC manager approval of test results for commercial product.
- Handling deviations, Invalid assays, Laboratory exceptions, CAPAs and Change Controls.
- Ensure compliance with cGMP and be key SME during audits and inspections.
The QC Chromatography team is currently consisting of 15 dedicated employees, including analysts, scientists, laboratory trainees, students, and managers. We support the biologic Drug Substance production as well as release testing of commercial products for our clients together with stability testing, method transfer, validation, and qualification for new customers.
About YouTo be successful in this role, you should have excellent collaboration skills and a strong understanding of cGMP requirements. You should be able to handle a busy environment with many changing priorities without losing your good mood and overview and still paying attention to details.
Estimated Salary: €80,000 - €120,000 per year-
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