Sr. Manager, Automation – GTx Lead

About the role

Novartis is looking for a Sr. Manager, Automation – GTx Lead to join its Durham, NC site as an onsite role. You will lead a high-performing team responsible for the IT/OT and automation systems that enable reliable, compliant and efficient manufacturing of next-generation gene therapies. The position sits within a fast-paced GMP environment and works closely with Engineering, Manufacturing, Quality and Technical Operations. Relocation support is not offered.

Key responsibilities

• Lead the design, implementation, maintenance and support of manufacturing automation systems and process equipment.
• Drive continuous improvement initiatives to improve 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, and lead automation-related deviation investigations and root cause analyses.
• Serve as the automation subject matter expert during regulatory inspections and internal or external audits.
• Partner with Engineering, Manufacturing, Quality and Technical Operations on new product introductions and site initiatives.

Required profile

• Bachelor's degree in Engineering or a related field with 9+ years of experience across IT/OT and automation platforms.
• Proven experience designing, operating, modifying, maintaining and retiring computerized systems in a regulated manufacturing environment.
• Demonstrated success leading technical teams and supporting complex 24/7 manufacturing operations.
• Ability to collaborate across Quality Engineering, Quality Assurance, Validation, Engineering and Manufacturing.
• Knowledge of FDA regulations, cGMP requirements and health, safety and environmental standards.

Required skills

• Strong expertise with DCS, PLC, SCADA, MES and Historian systems, and process equipment for drug substance and drug product manufacturing.
• Proficiency with Microsoft Office, CMMS and building management systems.
• Project management, quality compliance, risk management and stakeholder management.

What we offer

• Expected salary range of $114,100 to $211,900 per year, depending on skills and experience.
• Performance-based cash incentive and possible eligibility for annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match, and a time-off package including vacation, personal days and holidays.