Senior Scientist Biopharmaceutical Quality Control

5 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) dedicated to bringing hope to life by enabling life-changing therapies for patients around the globe. We create a healthier and happier tomorrow through our work side by side with customers to improve patients' lives by bringing new biopharmaceuticals to market.

We develop biopharmaceutical manufacturing processes and produce GMP-compliant biopharmaceutical proteins for both clinical testing and marketing. Our QC Bioassay department is one of five departments within our Quality Control organization. The team comprises 52 employees, including scientists and technicians, working in five groups: Bioassay Scientists, Bioassay Technicians, Cell & ELISA Based Methods, Reference & Critical Materials, and General Analytics.

As a Senior Scientist, you will join a team of eight colleagues and report to the Manager of the QC Bioassay Scientist team. Your tasks will involve reviewing and approving analytical results, method validation activities, and compliance documents related to quality control activities. Key responsibilities include:
  • Reviewing and approving analytical results from a range of methods.
  • Conducting method validations according to current ICH guidelines.
  • Participating in troubleshooting and scientific support on various bioassay methods.
  • Driving compliance documents related to quality control activities.
  • Collaborating with stakeholders within QC and cross-functional departments.
  • Ensuring all tasks are performed in accordance with cGMP regulations.
You will also be responsible for supporting review and approval of results outside normal working hours during manufacturing production as part of our on-call team.

The ideal candidate should thrive in a dynamic environment and be able to manage multiple tasks simultaneously. Key characteristics and capabilities include experience with bioassay methods, strong analytical mindset, structured and detail-oriented approach, hands-on experience with laboratory investigations, deviations, and CAPA, experience working in a cGMP setting according to EU and US guidelines, excellent communication skills, and fluency in English.

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