Lab Systems IT Manager - QC & Instrument Software

Regeneron; City of Rensselaer (NY); On-site; USD 92,200 - 176,000; Full time

Job summary

Regeneron seeks an IT Applications Manager — Lab Systems to lead the Lab Systems team across QC, Chemistry, Micro, and Virology labs. You will oversee lifecycle development, maintenance, and compliance of laboratory software, collaborating with QA, IT leadership, and cross-functional lab teams to ensure audit-ready systems.

The role requires strong leadership, cGMP knowledge, and experience with instrument software such as Endoscan V, SoftMax Pro, and DataPro2.

Qualifications

• Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11.
• Experience leading lab software lifecycle development, validation, and compliance.

Responsibilities

• Lead and develop the Lab Systems team overseeing benchtop computer systems and instrument software.
• Coordinate requirements gathering, system design priorities, and implementation timelines across labs.
• Ensure validated QC computers and software are maintained in a validated state and support audits.

Skills

Lab systems management

Regulatory compliance

Project management

ITIL knowledge

Education

Bachelor's degree in IT, science, engineering, CS, or related field

Tools

ServiceNow

Regulatory Asset Manager

Job description

Regeneron seeks an IT Applications Manager — Lab Systems to lead the Lab Systems team across QC, Chemistry, Micro, and Virology labs. You will oversee lifecycle development, maintenance, and compliance of laboratory software, collaborating with QA, IT leadership, and cross-functional lab teams to ensure audit-ready systems.

The role requires strong leadership, cGMP knowledge, and experience with instrument software such as Endoscan V, SoftMax Pro, and DataPro2.