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QC Bioassay Expert

1 week ago

Copenhagen, Copenhagen, Denmark AGC Inc Full time
About AGC Inc

AGC Inc 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 are seeking an experienced Senior Scientist to join our Quality Control (QC) General Analytics team in Copenhagen, Denmark. The QC Department is responsible for method validations, release testing, and stability study samples.

Our team is organized to support in-process stop/go testing 'outside normal working hours', i.e. evenings/nights, both on weekdays and weekends. We perform a broad range of compendial methods, bioassays, as well as cell-based assays.

As a Senior Scientist in QC General Analytics, you will work independently and participate in initiatives or projects to deliver to overall department objectives. Your responsibilities will include participating in analytical method validations, operational planning, ensuring all activities follow cGMP, and supporting regulatory inspections and customer audits.

Key Requirements:

  • Master's degree within life sciences
  • +3 years of work experience within the pharmaceutical industry working in a GMP environment and preferably in QC
  • Experience from working in a GMP environment and knowledge of relevant guidelines
  • Quality and structured mindset and preferably experience in writing and reviewing GMP documentation, including CR-cases, CAPAs, and deviations