QC Analytical Expert

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About Our Purpose

Our mission at AGC Biologics is to work hand-in-hand with our customers to bring new biopharmaceuticals to market. To achieve this goal, we are committed to developing biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins that meet the highest standards of quality and safety.

The Opportunity

We are seeking a Senior Scientist to join our QC Bioassay team, who will be responsible for ensuring the quality and safety of our products. The ideal candidate will have experience with bioassay methods and a strong analytical mindset, with the ability to troubleshoot complex issues. As a Senior Scientist, you will review and approve analytical results, method validations, and compliance activities, as well as participate in troubleshooting and scientific support on a broad range of bioassay methods.

Key Responsibilities
  • Review and approval of analytical results
  • Responsible for method validations according to current ICH guidelines
  • Participate in troubleshooting and scientific support on a broad range of bioassay methods
  • Drive compliance documents related to QC activities
  • Collaboration with multiple stakeholders both within QC and cross-functional departments including Analytical Development, Project Managers, and QA
  • Ensuring all tasks performed in cGMP compliance
Your Qualifications

The ideal candidate holds a M.SC. or Ph.D. degree in life sciences and has experience from the pharmaceutical industry, preferable from Quality Control or an Analytical Development department. We expect that you thrive working in a dynamic environment and able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing.

You will bring some of the following characteristics and capabilities:

  • Experience with bioassay methods
  • A strong analytical mindset and troubleshooting skills
  • Structured and detail-oriented but also demonstrate a pragmatic can-do attitude
  • Hands-on experience with handling laboratory investigations, deviations and CAPA's
  • Experience with working in a cGMP setting according to EU and US guidelines
  • Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
  • Fluency in English is a requirement as English is our corporate language
How to Apply

For further information regarding the position, please contact Agata Page, Manager of QC Bioassay. We treat the applications as we receive them and conduct interviews with qualified candidates.

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