Analytical Validations and Quality Control Specialist

5 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time
Job Overview

This is a temporary opportunity to join the QC Chemistry department as a Scientist and Subject Matter Expert for validations. The successful candidate will have expertise in troubleshooting chromatographic methods, particularly (U)HPLC, iCIEF, and CGE-SDS.

Responsibilities
  • Drive PhI/II and PhIII/commercial method validation activities
  • Review release and stability analytical set-ups
  • Support lab technicians, author SOPs, and run Lab Investigations, Deviations/CAPAs, and CR cases
  • Participate in method-relevant customer meetings and provide input for validation plannings
Requirements
  • MSc or PhD degree in Biochemistry, Chemistry, or other relevant area
  • Minimum 3 years of work experience in analytical development or quality control
  • Experience with SE-, IEX-, and RP-UHPLC, iCIEF, and CGE-SDS analysis
  • Technical experience in protein analytics testing and protein biochemistry
  • Fluent in written and spoken English


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