IT Lead, Manufacturing GxP

Regeneron Pharmaceuticals • Cambridge, MA

8d • Onsite

About The Position

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. This individual will ensure seamless communication, service delivery, and networking of points of contact across multiple IT groups and the business. The ideal candidate will have leadership and communication skills, experience in a GMP (Good Manufacturing Practices) environment, and the ability to troubleshoot on-site IT issues related to all Manufacturing and QC equipment and facilities IT systems. As an IT GxP Manufacturing Lead, a typical day may include: 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. This role could be for you if you: 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.

Requirements

• 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.
• 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.

Responsibilities

• 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.

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)

What This Job Offers

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