QC Technical Resources Specialist (Associate - Senior)

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

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. Regeneron is currently seeking a QC Technical Resources Specialist to join our QC Technical Resources team.

Where & When

Location: Raheen, Limerick

What You'll Do

• Supporting assay development/validation activities for the QC group from method readiness through to validation.
• Ensuring the operational readiness through management of sample / material requests.
• Coordinating analytical assay transfer internally and externally.
• Reviewing analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance.
• Communication of method updates to partners and tracks progress of updates.
• Coordinating multi‑site trending and reviews and communicates information as needed to subject matter experts.
• Supporting method lifecycle activities including method performance reporting, quality metrics and project timelines.
• Tracking team activities and timelines to ensure that the deliverables within the project plans are met and are on‑time.
• Communication to management for validation/transfer timelines.
• Continuously driving to improve processes for improved performance.

The Environment And Physical Rhythms Of This Role

• Strong ability to work independently and part of a global team.
• Proficient with the Microsoft suite and project management tools.
• Effective time management.
• Excellent written and verbal communication skills.
• Ability to develop strategies and metrics to measure effectiveness.
• Identifying and effectively communicating risks.

Let’s Find Out If We’re a Fit

• Associate Specialist: Requires BS/BA in a life sciences (or related) field and 0‑2 years experience or equivalent combination of education and experience.
• Specialist: Requires BS/BA in a life sciences (or related) field and at least 2 years of relevant experience in a cGMP environment or equivalent combination of education and experience.
• Senior Specialist: Requires BS/BA/MSc in a life sciences (or related) field and 4‑5 years of relevant experience in a cGMP environment or equivalent combination of education and experience.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary Range: €37,000.00 - €88,400.00