Staff External Manufacturing Specialist (Bioconjugation)

We are currently looking to fill a Staff External Manufacturing Specialist position within the Advanced Therapies External Manufacturing Team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role strategically manages Regeneron’s business relationships and supports end-to-end operations oversight with key Contract Manufacturing Organizations (CMOs) within Regeneron’s Bioconjugation portfolio.

As a Staff Specialist of External Manufacturing, a typical day might include the following:

• Lead Quarterly Business Reviews and other governance touchpoints with CMOs to drive performance, transparency, and continuous improvement.

• Lead RFP, SOWs, project plans, and change order management associated with contractor operations.

• Support and inform strategic initiatives and contract negotiations that drive long-term relationship stability and supply security.

• Provide regulatory filing support across global clinical and/or commercial submissions as it pertains to CMO activities.

• Lead external manufacturing activities at CMO and partner sites, including batch scheduling, material supply, product shipment, and cycle time monitoring.

• Support all External Manufacturing activities, including technical transfer, validation plans, Master Manufacturing Records (MRs), SOPs, and other documentation required for clinical and commercial manufacturing execution.

• Resolve supply issues with CMO/Partners affecting product quality or availability, including evaluating cost/benefit scenarios, making sound recommendations, and coordinating internal and external resources.

• Serve as the liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, MSAT, Operations/Logistics, and CMO/Partner sites.

• Collaborate with Tech Transfer, New Product Launch, Life Cycle Management teams to enable efficient product introductions and transitions.

• Ensure all manufacturing activities at CMO/Partner sites comply with cGMP requirements and applicable regulatory standards.

• Assist in monitoring cGMP compliance at contract manufacturers to protect product integrity and Regeneron's regulatory standing.

• Maintain current training status on all Regeneron-specific work instructions and SOPs.

• Develop and maintain metrics to analyze CMO network performance, departmental workload, and operational health.

This role might be for you if:

• You have Drug Substance/API manufacturing experience in Antibody Drug Conjugates (ADCs)/ other bioconjugate modalities (peptides, Peptides, Synthetic Oligonucleotides, or Monoclonal Antibodies.

• You have Sterile Drug Product filling experience.

• You thrive in environments where the scope is broad, the problems are ambiguous, and the expectation is that you build structure.

• You communicate with influence; you can align a CMO executive and a QA investigator in the same week without changing who you are.

• You are comfortable with travel to CMO/Partner sites as required (approximately 10–25%).

• You have led, or are ready to lead, direct reports or cross-functional teams

• You enjoy leading continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.

To be considered for the Staff Specialist of External Manufacturing, a BS/BA in business or scientific discipline and 10 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.

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)