Biotech Quality Control Professional

5 days ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time
About the Position

We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team.

As our Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products.

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.

Key responsibilities include reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories, collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs, and supporting regulatory filings and other interactions with Health Authorities.

This is a great opportunity to be part of a team ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team. Some travelling, on average 2-4 trips per year, is estimated in this role.



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