Manager - IT Applications Lab Systems

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an IT Applications Manager - Lab Systems (Associate Manager or Manager) to join our IOPS IT team, leading the Laboratory Systems team responsible for the lifecycle development, maintenance, and compliance of laboratory software across our QC, Chemistry, Micro, and Virology labs. In this role, you will oversee system administration, validation, and compliance activities for benchtop and instrument software systems - while collaborating with QA, IT leadership, and cross-functional lab teams to ensure systems are maintained in a compliant and audit-ready state. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide., * Lead and develop the Lab Systems team, overseeing system administration and enhancements for benchtop computer systems and instrument software including Endoscan V, SoftMax Pro, and DataPro2 across the Rensselaer site

• Supervise team performance management and people development activities; serve as technical coach and mentor for direct reports
• Coordinate requirements gathering, system design priorities, and implementation timelines across functional laboratory departments; develop and revise methods, record keeping, policies, and procedures in compliance with regulatory requirements
• Collaborate with QA to ensure validated QC computers and software are maintained in a validated state; implement change control following established procedures and support Laboratory validation activities following SDLC design methodology
• Investigate and resolve computer software and IT hardware issues with QC instrumentation; support preparation of teams for regulatory and internal audits
• Partner with business teams and IT leadership to help develop strategy for a growing organization and team; manage operational budgets and contribute to longer-term Lab Systems planning

• Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11; strong understanding of ALCOA+ principles and data integrity in biopharmaceutical production
• ITIL certification and project management training preferred
• Knowledge of helpdesk ticketing systems such as ServiceNow and Regulatory Asset Manager systems advantageous

This role requires:

• Bachelor’s degree in Information Technology, Science, Engineering, Computer Science, or a related field
• Associate Manager: 6+ years of relevant experience with 2+ years managing teams
• Manager: 7+ years of relevant experience with 3+ years managing teams
• May consider experience in lieu of education. Level is determined based on qualifications relevant to the role

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.