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 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.
Salary Range (annually)
$108,000.00 - $176,000.00
