Regeneron is looking for an Operations Specialist in Quality Control. This role serves as the single point of contact for counterpart teams, represents QC in cross-functional forums, and proactively monitors Certificates of Analysis (CoAs), testing progress, data review, and investigations. Using proven operational management techniques and deep QC domain knowledge, the Operations Specialist orchestrates activities across Quality Control to deliver on-time testing and QC outputs that enable batch release and key program milestones.
A typical day in this role may include:
- Monitors end-to-end progress of QC deliverables (testing, data review, investigations, CoAs) and coordinates resources and cross-functional communication to meet target dates.
- Coordinates QC for new modalities (e.g., cell and gene therapies, mRNA/LNP products, viral vectors, oligonucleotides, biologics), including modality-specific test panels and turnaround times.
- Maintains a real-time view of Work in Progress (WIP); tracks backlog, priorities, dependencies, and critical path to enable realistic scheduling and optimal resource alignment.
- Leverages a proficient understanding of QC processes and digital tools (e.g., LIMS, ELN, LES, chromatography data systems, eQMS, and business productivity/reporting tools) to manage work and communicate status.
- Uses dashboards and trackers to set clear, justified due dates for QC activities; navigates competing priorities and constructively challenges assumptions when needed.
- Proactively identifies team performance issues and process bottlenecks; drives issue management, escalations, and recovery plans to protect critical milestones.
- Builds strong working relationships with QC functional owners and cross-functional partners; facilitates efficient handoffs and transparent communication.
This position may be for you if:
- You’re familiar with relevant analytical and microbiological QC methods and data review expectations for advanced therapeutics.
- You have experience with digital QC systems (LIMS, ELN/LES, CDS, eQMS) and visualization tools (e.g., Power BI, Tableau).
- You can demonstrate contributions to continuous improvement initiatives (Lean, Six Sigma, Kaizen) within QC or laboratory operations.
To be considered for this position you must have a BS/BA in life sciences, or a related field.
Level will be determined based on qualifications.
- Specialist: Requires BS/BA and a minimum of 2+ years of industry experience.
- Senior Specialist: Requires BS/BA and 5+ years of industry experience, including 2 years in Quality Control or other laboratory experience,
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
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