IT Lead, Manufacturing GxP

Overview

We are seeking a skilled IT professional to serve as the IT Lead for Regeneron's Cell Medicines (RCM) Manufacturing operation to support and maintain all Clinical Manufacturing Equipment and data acquisition/monitoring systems. This role will require strong management skills to effectively manage the support needed from multiple Regeneron Corporate IT services groups and external support vendors as needed, in addition to strong technical skills as the primary On-Site IT SME for the Clinical Manufacturing area.

• Serve as the primary point of contact between RCM and Corporate IT, coordinating support across internal groups and external vendors.
• Align IT services with RCM’s needs by facilitating clear stakeholder communication on requirements, timelines, and deliverables.
• Lead planning and execution of IT projects and initiatives within a GMP environment, ensuring effective cross-team coordination.
• Provide regular operational and project status updates, metrics, and risk/issue reports to leadership.
• Manage and direct contracted IT personnel and oversee vendor performance for service delivery.
• Troubleshoot and resolve on-site IT issues for manufacturing, QC equipment, and facilities systems (hardware/software), ensuring rapid restoration.
• Ensure high availability and resilience of critical systems through monitoring, preventive maintenance, backups/archiving, and recovery readiness.
• Develop and maintain GxP documentation, including specifications, test protocols, validation/CSV records, and system administration SOPs.
• Support integration of equipment and systems with LIMS and other enterprise platforms in coordination with Corporate IT; supervise EMS for compliance and reliability.
• Ensure GMP/regulatory compliance by partnering with QA, managing IT tasks in CMMS, maintaining audit readiness, and driving continuous improvement of workflows and support processes.

• Strong management and leadership abilities.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively with cross-functional teams.
• Proven track record of collaborating with corporate IT teams.
• Ability to adapt to a fast-paced, multifaceted work environment.

• Bachelor’s degree in information technology, Computer Science, or a related field.
• 5 – 10 years  demonstrated ability in an IT role, preferably within a GMP-regulated environment.
• Proficiency in troubleshooting all IT aspects of manufacturing/QC equipment and other data collection/monitoring systems (e.g. EMS)
• Familiarity with GMP requirements and IT compliance standards.

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  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…