QC External Lab 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

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a QC External Laboratory Coordinator to join our Quality Control (QC) Support team.

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

When &where:

Location: Raheen, Limerick, Ireland. Flexibility & Travel: Occasional travel may be required to support external laboratory partnerships and audits. Other Requirements: Ability to work cross-functionally in a highly regulated Good Manufacturing Practice (GMP) environment.

What you'll do:

• 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, corrective and preventive actions, and Standard Operating Procedures (SOPs).

The Environment and Physical Rhythms of This Role:

This role is primarily office and laboratory-based within a Good Manufacturing Practice (GMP) regulated environment. May involve entering manufacturing, warehouse, or laboratory areas requiring appropriate gowning and personal protective equipment. Requires routine use of computer systems and the ability to review technical documentation and laboratory data.

Let’s find out if we’re a fit:

• Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific discipline, or equivalent relevant experience.
• Experience in quality control, analytical testing, microbiology, or external laboratory management within a regulated industry.
• Knowledge of Good Manufacturing Practice (GMP) requirements and quality systems.
• Experience with method transfers, investigations, change controls, or contract laboratory oversight is preferred.

Does this sound like you? We are committed to building a workplace with an inclusive culture.

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.