External Manufacturing Specialist, Clinical Pack & Label

Regeneron Pharmaceuticals, Inc.; New York; On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an External Manufacturing Specialist to oversee contract manufacturing operations (filling, assembly, packaging) for the Clinical Pack & Label team at our East Greenbush location in New York.

The role focuses on day-to-day activities, documentation, and cGMP compliance across multiple CMOs and business partner sites. Key duties include coordinating batch scheduling, material supply, shipment decisions, and monitoring cycle times, while liaising with

Qualifications

• BS/BA in a scientific discipline and experience in cGMP manufacturing operations.
• Experience collaborating with CMOs/CROs.
• Strong documentation and audit skills.
• Proficient with Excel and Office tools.

Responsibilities

• Serve as operational contact for external manufacturing and business partner sites.
• Coordinate scheduling of batches and supply of materials; oversee shipments of bulk or finished product.
• Monitor cycle times and prepare reports and supporting documentation.
• Lead or support investigations related to external manufacturing and shipping operations.
• Ensure cGMP compliance and product integrity across contract manufacturers.

Skills

cGMP experience

Contract coordination

Documentation

Excel proficiency

Education

BS/BA in a scientific discipline

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to an External Manufacturing Specialist position within the Clinical Pack & Label External Manufacturing team. The External Manufacturing Specialist oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel: up to 25%

Discover your role:

• Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
• Coordinates external manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise.
• Coordinates/oversees multiple external manufacturing activities at multiple sites, as required.
• Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
• Leads sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.
• Leads or supports all investigations which concern external manufacturing and associated shipping operations.
• Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
• Performs reviews of pre-production master batch records and executed batch records.
• Authors documents and procedures.
• Supports audit operations, both internal and external.
• Analyzes data for trends and potential issues.

This role requires:

• BS/BA in a scientific discipline and the following years of experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience, for each level: Associate Specialist - 0-2+ years
• Specialist - 2+ years
• Senior Specialist - 5+ years
• Level will be determined based on experience

Knowledge of external manufacturing from formulation through the final package.

Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.

Proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.

Strong interpersonal, written and oral communication skills.

Confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.

Ability to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.

A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.

Resiliency and flexibility in the face of challenges and adversarial situations.

Understanding and listening to team members and stakeholders needs while supporting productive team environments toward a common objective.

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 rewa