Biopharmaceutical Validation Expert

6 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

At AGC Biologics, we're committed to delivering the highest standard of service as we work side-by-side with our clients and partners. 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.

Skillful validation and method troubleshooting are essential in ensuring the quality of analytical testing for clinical and commercial manufacturing. As a Senior Scientist and Validation SME in QC Chemistry, 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.

We're looking for a highly motivated individual with expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. You'll participate in method relevant Customer meetings and provide input for validation plannings, requiring excellent communication skills and a general understanding of planning and coordination of activities.

Your ideal profile includes a MSc or PhD degree in Biochemistry, Chemistry or other relevant area, +3 years of work experience in QC or analytical development, and fluency in written and spoken English. Experience from PhIII Validations will have an added advantage.

  • You should 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 offer a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You'll get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success.

AGC offers exciting and challenging assignments that allow you to plan your daily work yourself. We respect each other and our individual differences, promoting a flexible attitude and teamwork. Our culture at AGC Biologics is defined by six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork.



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