Senior External Manufacturing Specialist

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.

Location and Travel

Raheen, Limerick. Travel: up to 25% (domestic and international) as required.

Responsibilities

• Serve as Regeneron's 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 to provide any required associated reports and technical expertise.
• Liaise between various departments within Regeneron including Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
• Lead a sub team in continuous process improvements, system/equipment implementation and/or strategy development.
• Support all investigations concerning external manufacturing and associated shipping operations.
• Ensure product integrity and company reputation by assisting in monitoring cGMP compliance at contract manufacturers and business partners.
• Perform reviews of pre production master batch records and executed batch records.

Knowledge and Skills

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

Qualifications

• 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.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include 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, and family support benefits. Salary range (annually) €46,200.00 - €88,400.00. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Equal Employment Opportunity

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.