QC Chemistry Team Lead

2 weeks ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

The QC Chemistry department at AGC Biologics is 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. As a QC Chemistry Team Lead, you will be 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 will hold a MSc or PhD degree in Biochemistry, Chemistry, or a relevant area alongside a minimum of 3 years of work experience in analytical development or quality control. Additionally, they should have 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 working in cGMP settings according to European and US regulatory guidelines.
  • Fluent in written and spoken English.

We are looking for someone with excellent communication, presentation, and interpersonal skills who can prioritize their own tasks in a dynamic environment, work independently as a team player, and bring a positive, can-do attitude and a good sense of humor.



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