CMC Development Quality Assurance Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

In this exciting role, you will join our growing department with an anticipated future expansion of new drug candidates. As a CMC Development Quality Assurance Specialist, you will support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the IMP for clinical trials.

Your responsibilities will include batch record review (Biologics and Small Molecules), QA assessment of deviations, change controls, and laboratory deviations, as well as approval of master batch records. You will work closely with multiple stakeholders in CMC and contribute to the continued development of our processes.

We are looking for a highly skilled individual with a master's degree in pharmacy, chemistry, biology, or a related field, and 1-2 years of experience in a GMP regulated environment in Manufacturing, Quality Control, or Quality Assurance. Sterile and biologic manufacturing knowledge is an advantage, as well as knowledge and experience within CMC.

This role offers great opportunities for growth and development, with a broad variety of tasks and responsibilities. You will work primarily in the DK time zone from our office in Valby.



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