Manager - IT Applications Lab Systems

About the role

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.

Responsibilities

• 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

Requirements

• 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

Qualifications

• 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

Skills

• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work effectively in a team environment
• Experience with laboratory informatics and software development

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.

Pay

$92,200.00 - $176,000.00 annually

Schedule

Monday - Friday 8am - 4:30pm