Staff External Manufacturing Specialist
Regeneron Pharmaceuticals, Inc, East Greenbush, NY, United States
Overview
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.
Responsibilities
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.
Qualifications & Experience
Drug substance/API manufacturing experience in Antibody Drug Conjugates (ADCs) or other bioconjugate modalities (peptides, synthetic oligonucleotides, or monoclonal antibodies).
Sterile Drug Product filling experience.
Comfortable with broad scope, ambiguous problems, and building structure.
Strong communication and influence skills; ability to engage CMO executives and QA investigators effectively.
Comfortable with 10–25% travel to CMO/Partner sites.
Experience leading or ready to lead direct reports or cross‑functional teams.
Enjoy leading continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiencies.
BS/BA in business or scientific discipline and 10 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or supplier management, or equivalent combination of education and experience.
Salary Range (annually): $108,000 - $176,000
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.
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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.
Responsibilities
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.
Qualifications & Experience
Drug substance/API manufacturing experience in Antibody Drug Conjugates (ADCs) or other bioconjugate modalities (peptides, synthetic oligonucleotides, or monoclonal antibodies).
Sterile Drug Product filling experience.
Comfortable with broad scope, ambiguous problems, and building structure.
Strong communication and influence skills; ability to engage CMO executives and QA investigators effectively.
Comfortable with 10–25% travel to CMO/Partner sites.
Experience leading or ready to lead direct reports or cross‑functional teams.
Enjoy leading continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiencies.
BS/BA in business or scientific discipline and 10 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or supplier management, or equivalent combination of education and experience.
Salary Range (annually): $108,000 - $176,000
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.
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