GMP Manufacturing Tech Support Lead

Novartis AG; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC seeks a Manager, Manufacturing Technical Support for an onsite role to lead a GMP manufacturing technical team. You will drive technical excellence, troubleshoot complex challenges, and implement CAPAs to maintain safe, compliant operations.

You will mentor talent and partner with Quality, Engineering, Manufacturing and Supply Chain to meet production objectives and ensure timely documentation and change control across the facility.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, or a related scientific discipline.

Responsibilities

• Lead and develop a high-performing Manufacturing Technical Support team supporting GMP production operations.
• Provide technical oversight and troubleshooting to resolve complex manufacturing and process challenges.
• Drive continuous improvement initiatives to enhance safety, quality, compliance, and operational efficiency.
• Partner with Manufacturing, Quality, Engineering, and other functions to achieve production objectives.
• Ensure timely investigation of deviations and implementation of effective CAPA activities.
• Support change control activities and assess manufacturing impact of process or equipment changes.
• Monitor process performance data and identify opportunities for reliability and productivity improvements.
• Oversee creation, review, and approval of GMP documentation, SOPs, and manufacturing records.
• Build team capabilities through coaching, training, performance management, and employee development.
• Maintain inspection readiness and ensure compliance with FDA, GMP, and company quality standards.

Skills

Leadership

GMP knowledge

FDA requirements

CAPA investigations

Root cause analysis

Problem solving

Cross-functional collaboration

Communication

Organizational skills

Education

Bachelor's degree in Life Sciences or related field

Job description

Novartis in Durham, NC seeks a Manager, Manufacturing Technical Support for an onsite role to lead a GMP manufacturing technical team. You will drive technical excellence, troubleshoot complex challenges, and implement CAPAs to maintain safe, compliant operations.

You will mentor talent and partner with Quality, Engineering, Manufacturing and Supply Chain to meet production objectives and ensure timely documentation and change control across the facility.