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QC Expert for Drug-Device Combination Products

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Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

Lundbeck A/S, H is seeking a highly skilled QC Expert for Drug-Device Combination Products to join our international CMC Biologics team. As our new expert, you will be responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team.

You will work closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, such as sampling plans, Certificate of Analysis, stability studies, method validation, etc. You will also review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.

This position requires excellent knowledge of GDP/GMP guidelines, the United States Pharmacopoeia, and the European Pharmacopoeia. Additionally, you should have a good understanding of methods used to test biological molecules, such as SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA.

The ideal candidate will have a strong background in pharmaceutical sciences, biochemistry, analytical chemistry, protein chemistry, biology, or equal. They should also possess advanced English verbal and written communication skills.