QC External Lab & Method Transfer Coordinator

Regeneron Pharmaceuticals, Inc.; Limerick; On-site; EUR 42,000 - 65,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC External Laboratory Coordinator to join the QC Support team in Raheen, Limerick, Ireland.

The role focuses on coordinating sample management and method transfers with external labs to support manufacturing and quality control operations. You will act as SME for analytical and microbiological transfers, collaborate with QA, Manufacturing, and contract labs, and help resolve quality issues while ensuring compliance with GMP and regulatory

Qualifications

• Bachelor's degree or equivalent in a scientific discipline with relevant lab experience.
• Experience in quality control and analytical testing in regulated environments.
• Knowledge of GMP requirements and quality systems.
• Experience with method transfers or external laboratory oversight is preferred.

Responsibilities

• Coordinate sample management and method transfer activities with external laboratories supporting manufacturing and quality control operations.
• Serve as a technical subject matter expert for analytical and microbiological method transfers, ensuring successful execution and compliance.
• Partner with Quality Assurance, Manufacturing, and external laboratories to resolve quality issues, investigations, and technical challenges.
• Review and approve method transfer documentation, quality records, and laboratory reports to support regulatory compliance.
• Drive continuous improvement initiatives while maintaining quality systems, including change controls, CAPAs, and SOPs.

Skills

Quality control

Analytical testing

Microbiology

External laboratory management

Education

Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific discipline, or equivalent relevant experience

Job description

Regeneron Pharmaceuticals, Inc. is seeking a QC External Laboratory Coordinator to join the QC Support team in Raheen, Limerick, Ireland.

The role focuses on coordinating sample management and method transfers with external labs to support manufacturing and quality control operations. You will act as SME for analytical and microbiological transfers, collaborate with QA, Manufacturing, and contract labs, and help resolve quality issues while ensuring compliance with GMP and regulatory