Senior External Manufacturing Specialist

Regeneron; Limerick; On-site; EUR 46,200 - 88,400; Full time

Job summary

Regeneron is seeking a Senior External Manufacturing Specialist to join the Drug Product Manufacturing team in Raheen, Limerick. This role involves coordinating external manufacturing activities across contract manufacturers and partners, scheduling batches, and ensuring product integrity.

You will liaise with Quality Control, QA, Supply Chain, Operations, and contract manufacturers, leading continuous improvement efforts while supporting investigations related to external manufacturing and

Qualifications

• BS/BA in a scientific discipline required.
• 5 years of related experience in cGMP manufacturing operations for Senior Specialist.
• Strong interpersonal, written and oral communication skills required.

Responsibilities

• Serve as Regeneron operational contact for contract manufacturing and partner sites.
• Coordinate external manufacturing activities at contract and partner sites.
• Schedule all batches, supply materials and direct shipment of bulk or finished product.
• Track cycle times and provide supporting documentation for manufacturing activities.

Skills

Communication skills

Interpersonal skills

Education

BS/BA in a scientific discipline

Tools

Excel

PowerPoint

Visio

Word

Job description

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. Regeneron is currently seeking a Senior External Manufacturing Specialist to join our Drug Product Manufacturing 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.
• Travel: up to 25% (domestic and international), as required.

What You’ll Do

• Serve as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day‑to‑day activities.
• Coordinate external manufacturing activities at contract and/or business partner sites.
• Schedule all batches, supply materials and provide direction on shipment of bulk or finished product.
• Track and monitor cycle times, provide supporting documentation for manufacturing activities and enlist support from others who will provide associated reports and technical expertise.
• Liaise between various departments within Regeneron including, but not limited to, Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract manufacturers or business partners.
• Lead a sub‑team in continuous process improvements, system/equipment implementation and/or strategy development.
• Support all investigations which concern external manufacturing and associated shipping operations.
• Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
• Perform reviews of pre‑production master batch records and executed batch records.

The Environment and Physical Rhythms of This Role

• Knowledge of external manufacturing from formulation through the final package.
• Basic knowledge of regulatory compliance, including cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficiency in Excel, PowerPoint, Visio, Word, etc., and experience working within shared work environments.
• Strong interpersonal, written, and oral communication skills.

Let’s Find Out If We’re a Fit

• Associate Specialist: Requires BS/BA in a scientific discipline.
• Specialist: Requires BS/BA in a scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or an equivalent combination of education and experience.
• Senior Specialist: Requires BS/BA in a scientific discipline and 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or an equivalent combination of education and experience.

Salary Range (annually)

€46,200.00 – €88,400.00

Regeneron is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, age, disability, nationality, citizenship status, genetic information, trade union status, veteran status, or any other characteristic protected under applicable law. Reasonable accommodation will be provided when required.

Background checks may be conducted in accordance with applicable laws.