Senior Scientist, QC BioAssay

Senior Scientist, QC BioAssay

Genmab

Ballerup, Denmark

The Role as Senior QC Scientist (BioAssay)

Are you motivated by the opportunity to help build something from the ground up? Genmab is establishing a QC Laboratory, and we are looking for a Senior QC Scientist for a BioAssay team to play a central role in this work.

This is a unique opportunity to help implement methods, shape key processes, and set the standard for how our QC organization will operate in the years ahead.

You will play a key role in the establishment of the laboratory which includes and is not limited to: Method transfers, Validation of Analytical methods, authoring and reviewing laboratory procedures, and supporting qualification of new analytical instruments.

Collaboration and cross-site training with our analytical development group in Utrecht and analytical SME´s in Copenhagen will also be expected in the beginning.

The position is an onsite role in our QC Lab in Ballerup and reports to Associate Director, Head of QC BioAssay.

Once in operation daily tasks includes:

• Reviewing release and stability analyzes;
• Supporting and training fellow scientists and lab technicians;
• Documenting validation activities of analytical methods for clinical phase I/II and III and authoring SOPs.

Requirements

• Master's degree or PhD in chemistry, biology, pharmacy, biotechnology, or related scientific area.
• At least 6+ years of experience in a Quality Control (QC) or analytical development (AD) laboratory or a PhD degree with 3+ years of working experience.
• Strong understanding of analytical science and its application across clinical development stages.
• Good understanding of validation concepts, risk-based approaches, and regulatory expectations.
• Experience with systems and tools relevant to QC (e.g. LIMS, SAS-Jmp, SoftMaxPro)
• You have experience with ELISA´s and pharmacopeia methods for biologics.