QC Chemistry Method Validator and SME

6 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

We're a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

Job Description:

This role requires expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. 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.

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, requiring fluency in written and spoken English.

  • 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.

We're looking for a self-motivating personality with a pragmatic, solution-oriented approach to the daily work, without compromising quality. You'll thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team.

Our employees value flexibility and mutual respect. We promote continuous innovation and technical creativity to solve our clients' most complex challenges. We currently employ more than 2,500 employees worldwide, with operations spanning the U.S., Europe, and Asia.



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