Manager - IT Applications Lab Systems

Regeneron Pharmaceuticals • Rensselaer, IN

1d • Onsite

About The Position

The Manager - IT Applications Lab Systems position leads the Laboratory Systems team within the Information Technology function and is responsible for managing the system lifecycle development, maintenance and compliance activities for Laboratory software systems in our QC, Chemistry, Micro and Virology labs. These systems include but are not limited to bench top computer systems and instrument software such as Endoscan V, SoftMax Pro and DataPro2. As a Manager, a typical day might include the following, Manages team responsible for local operations, system administration and enhancements of bench top computer systems and instrument software such as Endoscan V, SoftMax Pro and DataPro2.across the Rensselaer site. Supervises the Lab Systems team including performance management and people development activities. Work with business teams and IT leadership to help develop strategy for a growing organization and team. Technical coach and mentor for resources in their direct organization. Coordinates the needs of functional departments and establishes priorities for Laboratory Systems requirements gathering, system design and implementation. Develops and revises methods, record keeping, policies and procedures for Laboratory Systems in compliance with regulations and guidance. Investigates and resolves computer software and IT hardware issues with QC instrumentation. Collaborates with relevant QA organizations to ensure validated QC computers and software are maintained in a validated state. Implements change control following established procedures. Supports validation of Laboratory following SDLC design methodology. Performs related duties as assigned. Supports and prepare the teams for regulatory and internal audits.

Requirements

• Recognize the importance of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production, should display a high level of integrity in the performance of his/her work.
• Passionate about quality / right first time.
• Organized and good documentation skills.
• Proven ability to support Applications in a highly regulated environment.
• Knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11.
• Excellent written and oral communication skills.
• Good IT skills and knowledge of standard software packages (e.g., Microsoft Word, Excel, Teams etc.,).
• Possess excellent customer facing skills allowing comfortable traversing of cross departmental levels.
• Ability to think analytically and learn quickly.
• Manage Operational budgets.
• Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field and Associate Manager: 6+ years of experience, 2+ years of managing teams. Manager: 7+ years of experience, 3+ years of managing teams.

Nice To Haves

• Knowledge of helpdesk ticketing systems such as Service Now advantageous.
• Knowledge of Regulatory Asset Manager Systems advantageous.
• ITIL certified.
• Project Management trained.
• GMP Laboratory/IT setting preferred.
• May consider experience in lieu of education.

Responsibilities

• Manages team responsible for local operations, system administration and enhancements of bench top computer systems and instrument software such as Endoscan V, SoftMax Pro and DataPro2.across the Rensselaer site.
• Supervises the Lab Systems team including performance management and people development activities.
• Work with business teams and IT leadership to help develop strategy for a growing organization and team.
• Technical coach and mentor for resources in their direct organization.
• Coordinates the needs of functional departments and establishes priorities for Laboratory Systems requirements gathering, system design and implementation.
• Develops and revises methods, record keeping, policies and procedures for Laboratory Systems in compliance with regulations and guidance.
• Investigates and resolves computer software and IT hardware issues with QC instrumentation.
• Collaborates with relevant QA organizations to ensure validated QC computers and software are maintained in a validated state.
• Implements change control following established procedures.
• Supports validation of Laboratory following SDLC design methodology.
• Performs related duties as assigned.
• Supports and prepare the teams for regulatory and internal audits.

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: Manager
• Number of Employees: 5,001-10,000 employees