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Cambridge, Massachusetts, United States
Onsite
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.
To be considered for this role, you must meet the following:
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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$80,300.00 - $131,100.00