QC Resources Specialist: Method Validation & Transfer

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 37,000 - 88,400; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick, Ireland, is seeking a QC Technical Resources Specialist to join the QC Technical Resources team. You will support assay development and validation, manage material requests, and coordinate analytical transfer.

The role emphasizes regulatory compliance, technical document review, progress tracking, and driving process improvements within a global, collaborative environment.

Qualifications

• BS/BA in a life sciences field or related, with 0-2 years experience for Associate Specialist; more for Specialist.
• Experience in a cGMP environment preferred for Specialist/Senior Specialist.
• Strong documentation and regulatory compliance understanding.

Responsibilities

• Support assay development and validation activities from method readiness to validation.
• Ensure operational readiness through management of sample/material requests.
• Coordinate analytical assay transfer internally and externally.
• Review analytical development reports, assay and process validation reports for technical correctness.
• Communicate method updates to partners and track progress.
• Coordinate multi-site trending and reviews with subject matter experts.
• Support method lifecycle activities including performance reporting and timelines.
• Track team activities to meet project deliverables on time.
• Communicate validation/transfer timelines to management.
• Drive process improvements for better performance.

Skills

Independent work

Communication skills

Time management

Teamwork

Attention to detail

Education

BS/BA in life sciences

MSc in life sciences

Tools

Microsoft Office

Project management tools

Job description

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick, Ireland, is seeking a QC Technical Resources Specialist to join the QC Technical Resources team. You will support assay development and validation, manage material requests, and coordinate analytical transfer.

The role emphasizes regulatory compliance, technical document review, progress tracking, and driving process improvements within a global, collaborative environment.