Product Specification Specialist

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Product Specification Specialist (Associate through Senior level) to join our Quality team, supporting the creation, revision, and lifecycle management of Product Specification Documents across our biopharmaceutical operations. In this role, you will collaborate cross-functionally to ensure product specifications remain compliant with regulatory filings and site procedures, while contributing to quality risk assessments and deviation investigations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Troy, New York, United States
• Work model: Monday - Friday 8am - 4:30pm

Discover your role:

• Initiate, revise, and retire product specifications within Regeneron's Quality Systems, ensuring compliance with site procedures and current regulatory filings and commitments
• Collaborate cross-functionally to define content for new and revised Product Specification Documents, partnering with associated departments to assess the impact of changes
• Conduct Quality Risk Management assessments to identify failure modes and establish appropriate risk controls
• Support deviation investigations involving product specifications, applying subject matter expertise to identify root causes and contribute to resolution strategies
• Identify project issues and contribute to the development of alternative approaches to keep work on track
• Actively participate in cross-functional meetings, presenting updates and contributing to shared quality objectives
• Experience with or knowledge of biopharmaceutical testing or manufacturing preferred; knowledge of USP/EP compendia requirements and ICH guidelines a plus

This role requires:

• BS/BA in a scientific discipline
• Associate Specialist: 0–2 years of relevant experience
• Specialist: 2+ years of relevant experience
• Senior Specialist: 5+ years of relevant experience
• May consider equivalent combination of education and experience; level determined based on qualifications

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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/. 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.

Salary Range (annually)