Gene Therapy Automation Lead for 24/7 GMP Ops

Novartis; Durham (NC); On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis in Durham, NC seeks a Sr. Manager, Automation – GTx Lead to drive strategy and lead a high‑performing IT/OT and automation team in a GMP environment.

You will own critical systems, mentor engineers, and align site automation with global standards to enable reliable manufacturing of next‑generation therapies. This onsite role requires strong leadership, cross‑functional collaboration with Quality, Engineering, Manufacturing and Technical Operations, and proven ability to deliver 24/7

Qualifications

• 9+ years of experience across IT/OT and automation platforms.
• Experience designing, operating, modifying, maintaining, and retiring computerized systems in a regulated manufacturing environment.
• Knowledge of FDA regulations, cGMP requirements, and health, safety, and environmental standards.

Responsibilities

• Lead the design, implementation, maintenance, and support of manufacturing automation systems and process equipment.
• Drive continuous improvement initiatives to enhance automation performance, reliability, and innovation.
• Execute site automation strategies aligned with global Novartis standards and best practices.
• Own and oversee computerized systems supporting critical manufacturing processes.
• Lead, mentor, and develop a team of automation engineers supporting 24/7 operations.
• Establish and improve KPIs to maximize system reliability, availability, and operational excellence.
• Own change controls and CAPAs to drive compliance and continuous improvement.
• Lead automation-related deviation investigations and provide SME expertise for root cause analysis.
• Serve as the automation SME during regulatory inspections and audits.
• Partner with Engineering, Manufacturing, Quality, and Technical Operations to support new product introductions and site initiatives.

Skills

Leadership

Problem solving

Planning

Decision making

Communication

Education

Bachelor's degree in Engineering or related field

Tools

DCS

PLC

SCADA

MES

Historian systems

Process equipment

Job description

Novartis in Durham, NC seeks a Sr. Manager, Automation – GTx Lead to drive strategy and lead a high‑performing IT/OT and automation team in a GMP environment.

You will own critical systems, mentor engineers, and align site automation with global standards to enable reliable manufacturing of next‑generation therapies. This onsite role requires strong leadership, cross‑functional collaboration with Quality, Engineering, Manufacturing and Technical Operations, and proven ability to deliver 24/7