QC Method Transfer & Validation Specialist

Regeneron; Limerick; On-site; EUR 37,000 - 88,400; Full time

Job summary

Regeneron in Ireland (Raheen, Limerick) seeks a QC Technical Resources Specialist to support assay development and validation within the QC Technical Resources team. You will coordinate sample requests, transfer analytically, and review reports to ensure regulatory compliance.

You will collaborate with global teams, communicate method updates, track timelines, and drive process improvements to enhance quality and efficiency across projects in a cGMP environment.

Qualifications

• BS/BA in life sciences with 0–2 years experience (Associate Specialist) in a life sciences/cGMP setting.
• BS/BA in life sciences with ≥2 years in a cGMP environment (Specialist).
• BS/BA/MSc in life sciences with 4–5 years in a cGMP environment (Senior Specialist).

Responsibilities

• Support assay development/validation from readiness through validation.
• Ensure operational readiness via management of sample/material requests.
• Coordinate analytical assay transfer internally and externally.
• Review analytical development and validation reports for technical accuracy and regulatory compliance.
• 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 metrics.
• Track team activities and timelines to meet project plans.
• Communicate validation/transfer timelines to management.
• Drive process improvements for better performance.

Skills

Project management

Time management

Written and verbal communication

Independent work

Cross-functional collaboration

Education

BS/BA in life sciences (or related) field

Tools

Microsoft Office Suite

Project management tools

Job description

Regeneron in Ireland (Raheen, Limerick) seeks a QC Technical Resources Specialist to support assay development and validation within the QC Technical Resources team. You will coordinate sample requests, transfer analytically, and review reports to ensure regulatory compliance.

You will collaborate with global teams, communicate method updates, track timelines, and drive process improvements to enhance quality and efficiency across projects in a cGMP environment.