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Director, GMP AI Engineering
Regeneron
2 hours ago
Full-time
On-site
Troy, New York, United States
Director, Ai Engineering
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, AI Engineering to lead the AI function for our Industrial Operations and Product Supply (IOPS) organization
spanning governance and compliant operation of AI in a regulated environment, delivery of IOPS-specific AI use cases, and the education and enablement programs that drive adoption across the business. In this role, you will translate AI capability into adopted, measurable value
partnering with Quality, enterprise AI, and senior leaders across IOPS
while leading and developing a high-performing multidisciplinary team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Location: Troy, New York Work model/flexibility: 8am - 4:30pm Discover your role: Own and execute the IOPS AI roadmap in alignment with business goals, including use-case intake, prioritization, and value measurement across a mature and growing project portfolio Operate and evolve AI governance within a GMP environment
maintaining the IOPS AI policy and governance framework, computer system classification, validation procedures, qualified access, and data integrity
in close partnership with Quality and functional stakeholders Sustain audit and inspection readiness for AI systems and governance processes; represent IOPS AI practices to internal and external assessors Deliver IOPS-specific AI use cases end to end with an established multidisciplinary team, from business-need translation through deployment, adoption, and measured value Lead AI education and enablement across IOPS
including fluency curricula for audiences from operators to executives, an embedded advocate network, and engagement channels that convert demand into adoption Partner with Regeneron's enterprise AI organization to adopt corporate platforms, tools, and standards, adapting them for GMP use rather than building parallel capability Translate between technology and leadership, communicating AI strategy, risk, and value clearly to senior leaders across the organization Lead, develop, and mentor an established high-performing team, fostering a culture of innovation and continuous learning This role requires: BS/BA in Engineering, Science, or a related technical discipline Associate Director: 10+ years of industry experience required Director: 12+ years of industry experience required Equivalent combination of education and experience considered; level determined based on qualifications Proven experience leading applied AI programs across governance, delivery, and education or adoption in a regulated environment Direct experience operating AI or computerized systems in a GMP/GxP environment, including computer system validation, system classification, data integrity, and inspection readiness; pharmaceutical manufacturing or similarly regulated environment strongly preferred Track record of delivering AI and intelligent automation use cases with measurable business value in manufacturing or operations settings Experience building education, fluency, or enablement programs and champion or advocate networks that scale adoption without proportional headcount growth Working fluency with the modern AI landscape including language models, machine learning, and intelligent automation, with sufficient technical depth to lead engineers, evaluate solutions, and govern systems credibly Familiarity with Responsible AI principles; experience with model risk, model credibility, or AI validation and assurance frameworks a plus Demonstrated ability to lead through influence across organizational lines and advocate effectively for AI initiatives with executive audiences
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, AI Engineering to lead the AI function for our Industrial Operations and Product Supply (IOPS) organization
spanning governance and compliant operation of AI in a regulated environment, delivery of IOPS-specific AI use cases, and the education and enablement programs that drive adoption across the business. In this role, you will translate AI capability into adopted, measurable value
partnering with Quality, enterprise AI, and senior leaders across IOPS
while leading and developing a high-performing multidisciplinary team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Location: Troy, New York Work model/flexibility: 8am - 4:30pm Discover your role: Own and execute the IOPS AI roadmap in alignment with business goals, including use-case intake, prioritization, and value measurement across a mature and growing project portfolio Operate and evolve AI governance within a GMP environment
maintaining the IOPS AI policy and governance framework, computer system classification, validation procedures, qualified access, and data integrity
in close partnership with Quality and functional stakeholders Sustain audit and inspection readiness for AI systems and governance processes; represent IOPS AI practices to internal and external assessors Deliver IOPS-specific AI use cases end to end with an established multidisciplinary team, from business-need translation through deployment, adoption, and measured value Lead AI education and enablement across IOPS
including fluency curricula for audiences from operators to executives, an embedded advocate network, and engagement channels that convert demand into adoption Partner with Regeneron's enterprise AI organization to adopt corporate platforms, tools, and standards, adapting them for GMP use rather than building parallel capability Translate between technology and leadership, communicating AI strategy, risk, and value clearly to senior leaders across the organization Lead, develop, and mentor an established high-performing team, fostering a culture of innovation and continuous learning This role requires: BS/BA in Engineering, Science, or a related technical discipline Associate Director: 10+ years of industry experience required Director: 12+ years of industry experience required Equivalent combination of education and experience considered; level determined based on qualifications Proven experience leading applied AI programs across governance, delivery, and education or adoption in a regulated environment Direct experience operating AI or computerized systems in a GMP/GxP environment, including computer system validation, system classification, data integrity, and inspection readiness; pharmaceutical manufacturing or similarly regulated environment strongly preferred Track record of delivering AI and intelligent automation use cases with measurable business value in manufacturing or operations settings Experience building education, fluency, or enablement programs and champion or advocate networks that scale adoption without proportional headcount growth Working fluency with the modern AI landscape including language models, machine learning, and intelligent automation, with sufficient technical depth to lead engineers, evaluate solutions, and govern systems credibly Familiarity with Responsible AI principles; experience with model risk, model credibility, or AI validation and assurance frameworks a plus Demonstrated ability to lead through influence across organizational lines and advocate effectively for AI initiatives with executive audiences