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QC Assay Validation Expert

1 week ago

Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

**Job Overview**

We are looking for a talented QC Assay Validation Expert to join our team at Regeneron Ireland DAC. In this role, you will play a critical part in ensuring the quality and accuracy of our assays through rigorous validation and investigation activities.

Your key responsibilities will include:

  • Validating assay performance through yearly method performance reports
  • Evaluating and implementing new methodologies, techniques, and equipment
  • Generating and/or supporting compliance records, CAPAs, change controls, and deviation notifications as needed

As a Senior QC Scientist, you will work collaboratively with cross-functional teams to drive scientific and business-related improvement initiatives. You will participate in training programs for analysts, support regulatory inspections, and contribute to the development of technical documents.

To succeed in this role, you should possess a strong understanding of analytical chemistry and a proven track record in QC assay validation and development. A PhD in Microbiology, Chemistry, Biology, or a related field is desired, along with 2+ years of experience in the pharmaceutical or biotechnology industries.