Senior Scientist

5 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

We're seeking a skilled expert to support clinical and commercial manufacturing for our Customers worldwide. The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area, with +3 years of work experience in QC or analytical development. Fluency in written and spoken English is required, since English is our company language.

The QC Chemistry Department:

QC Chemistry is one of five departments in the QC area. We're responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. We have a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.

In this role, you'll drive PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs and running Lab Investigations, Deviations/CAPAs and CR cases. Your expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS, will be invaluable.

Excellent communication skills and a general understanding of planning and coordination of activities are essential. You'll participate in method relevant Customer meetings and provide input for validation plannings. Experience from PhIII Validations will have an added advantage.

  • You'll have working and troubleshooting experience with SE-, IEX- and RP-UHPLC, iCIEF and CGE-SDS analysis.
  • Experience with Chromeleon software and LIMS is also required.
  • Technical experience in protein analytics testing and protein biochemistry is essential.
  • You'll be validating analytical methods according to ICH guidelines for PhI/II and/or PhIII.
  • Working in cGMP settings according to European and US regulatory guidelines is necessary.

Our company culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. These core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents.


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