Staff External Manufacturing Specialist

Regeneron Pharmaceuticals • Valley, AL

1d • $108,000 - $176,000 • Onsite

About The Position

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. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

• BS/BA in business or scientific discipline
• 10 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience

Nice To Haves

• Drug Substance/API manufacturing experience in Antibody Drug Conjugates (ADCs)/ other bioconjugate modalities (peptides, Peptides, Synthetic Oligonucleotides, or Monoclonal Antibodies)
• Sterile Drug Product filling experience
• Thrive in environments where the scope is broad, the problems are ambiguous, and the expectation is that you build structure
• Communicate with influence; you can align a CMO executive and a QA investigator in the same week without changing who you are
• Comfortable with travel to CMO/Partner sites as required (approximately 10–25%)
• Led, or are 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 for area

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.

Benefits

• 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
• paid leaves (e.g., military and parental leave) for eligible employees at all levels!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees