Biotechnology Professional

4 days ago


Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

Lundbeck A/S, H is seeking a highly skilled professional to join its team as a QA Academic in the CMC Development department.

As a member of our team, you will be responsible for ensuring patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials. Your role will involve batch record review, QA assessment of deviations, change controls, and laboratory deviations, as well as approval of master batch records.

You will collaborate with multiple stakeholders in CMC and contribute to the continued development of our processes. The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who work together to ensure efficient and compliant quality processes to support the development of Small Molecule and Biologic drug candidates.

We are looking for an individual with a master's degree in pharmacy, chemistry, biology, or a similar field. Prior experience in a GMP regulated environment in Manufacturing, Quality Control, or Quality Assurance is preferred. Sterile and biologic manufacturing knowledge is also an advantage. You should be fluent in English and have strong communication skills.

At Lundbeck, we offer a dynamic and innovative work environment where you can grow your skills and knowledge. We are committed to transforming lives by addressing the big unmet needs of people living with brain disorders. If you are passionate about quality assurance and want to make a meaningful contribution to our mission, please submit your application.



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