Lead Analytical Chemist

4 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time
Job Title: Senior Scientist Validation

We are seeking a highly skilled and experienced Scientist to join our QC Chemistry team as a Subject Matter Expert (SME) for validations. As an SME, you will be responsible for driving 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.

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. Additionally, we are looking for someone with one or more of the following skills:

  • 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
  • Fluent in written and spoken English


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