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Subject Matter Expert in Biologicals

vor 2 Monaten


Kiel, Schleswig-Holstein, Deutschland Ferring Pharmaceuticals Vollzeit
About the Role

Ferring Pharmaceuticals is a leading biopharmaceutical company that pioneers and delivers life-changing therapies to help people build families and live better lives. As a Subject Matter Expert in Biologicals, you will be part of the Global Manufacturing Technology and Science (MTS) department, which is at the interface between development and manufacturing operations.

Key Responsibilities
  • Identify and lead initiatives on bioassay robustness.
  • Lead, design, and follow-up experimental studies with third-party laboratories.
  • Support the introduction, implementation, and validation of bioanalytical methods into the manufacturing organization for GMP release.
  • Drive and/or support troubleshooting activities related to bioassays using root cause analysis tools.
  • Support/drive part of the 3Rs program (Replacement, Reduction, and Refinement).
  • Advocate best practices for specific biological analytical methods.
  • Participate in cross-functional projects as a bioassay SME team member.
  • Author and maintain relevant SOPs, guidelines, and tools.
  • Create, maintain, expand, and continuously update scientific knowledge based on the technologies in scope.
Requirements
  • Master of Science or equivalent in a relevant field such as cellular biology, virology, immunology.
  • A minimum of 5 years of knowledge in biological analytical methods for biologics and large molecules.
  • Subject matter expert for biologicals methods in accordance with cGMP, ICH guidelines, and pharmacopoeia requirements.
  • Solid technical skills and experiences in:
    • Potency assays (cell-based assay, in vivo bioassay, ELISA).
    • Verification and validation of bio-analytical methods.
    • Analytical transfer.
    • Troubleshooting activities/root-cause analysis.