QC Technical Resources Specialist (Associate - Senior)

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location: Raheen, Limerick

• 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.

• 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.

• 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.

We are committed to building a workplace with an inclusive culture. 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 (annually) €37,000.00 - €88,400.00