Senior Validation Specialist

2 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. 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.

We are seeking an experienced Senior Validation Specialist to join our team in QC Chemistry. As a key member of our department, you will be responsible for 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:

  • 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

What We Offer:

  • A dynamic working place with good opportunities of working with a varied array of tasks and challenges
  • Exciting and challenging assignments
  • An informal working environment, where humor is part of the daily work life


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