Analytical Validation Specialist

23 hours ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time
Job Description:

As an Analytical Validation Specialist at AGC Biologics, you will be responsible for driving PhI/II and PhIII/Commercial method validation activities. You will review release and stability analytical set-ups, support lab technicians, author SOPs, and run Lab Investigations, Deviations/CAPAs, and CR cases.

The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry, or other relevant area alongside a minimum of 3 years of work experience in analytical development or quality control.

You should have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF, and CGE-SDS. Good communication skills are essential together with a general understanding of planning and coordination of activities.

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


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