Compliance Specialist, External Manufacturing

Regeneron Pharmaceuticals, Inc (USA); New York (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist for the External Manufacturing team in East Greenbush, NY. This role focuses on operations support and compliance activities for Regeneron product manufacturing.

The candidate will lead change controls, SCARs, CAPAs, and reviews of cGMP documentation, contributing to audit readiness and continuous improvement. A BS in a scientific field with cGMP experience is preferred.

Qualifications

• BS/BA in scientific field with cGMP manufacturing experience.
• Knowledge of drug product manufacturing from formulation through final package.
• Regulatory compliance knowledge incl. cGMP, FDA, ICH, EU.
• Proficient in Veeva, Opstrakker, Office suite.
• Strong interpersonal and written/oral communication.

Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support both internal and external inspection and audit readiness activities.
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
• Maintain required training status on Regeneron specific work instructions and SOPs.
• Continuous process improvement implementation.

Skills

cGMP

Veeva

Excel

Regulatory compliance

Documentation handling

Communication skills

CMOs/CROs collaboration

Education

BS/BA in scientific field

Tools

Veeva

Opstrakker

Excel

PowerPoint

Visio

Word

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 fill a Compliance Specialist position within the External Manufacturing team. This role is responsible for operations support and compliance related activities for the manufacturing of Regeneron products.

When & where:

Location: East Greenbush, New York, United States

Work schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• Lead and manage change controls, SCARs, SCN’s, NPCs, and CAPAs
• Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement
• Maintain knowledge of current good manufacturing practices (cGMPs)
• Support both internal and external inspection and audit readiness activities
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
• Maintain required training status on Regeneron specific work instructions and SOPs
• Continuous process improvement implementation

This role requires:

• BS/BA in scientific field and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial for each level: Associate Specialist – 0-2 years Specialist – 2+ years Sr Specialist – 5+ years Level will be determined based on experience)
• Knowledge of drug product manufacturing from formulation through the final package
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
• Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
• Strong interpersonal, written and oral communication skills, with an emphasis on technical writing
• Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates
• Shows resiliency and flexibility in the face of challenges and adversarial situations
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective
• Experience in collaborating with CMOs/CROs is preferred

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, and 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/.

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.

Salary Range (annually) $62,355.00 - $128,700.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.