Validation SME in QC Chemistry

3 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

We are a collaborative and supportive team, working together to achieve our goals. Our team in QC Chemistry is no exception, and we are seeking an experienced Validation SME in QC Chemistry to join us.

As a key member of our department, you will be responsible for method validations, troubleshooting and supporting analytical quality control (QC) activities in order to support clinical and commercial manufacturing for our Customers worldwide. You will also 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 holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has +3 years of work experience in QC or analytical development. Candidates with experience from PhIII Validations will have an added advantage. Fluency in written and spoken English is a requirement, since English is our company language.

Your Key Responsibilities:

  • Method validations, troubleshooting and supporting analytical quality control (QC) activities
  • 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
],

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