Senior MS&T Engineer, Gene Therapy Manufacturing

Novartis Group Companies; Durham (NC); On-site; USD 126,000 - 234,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time-off

Job summary

Novartis Group of Companies in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guiding investigations and driving continuous improvement to ensure high-quality, reliable products.

You will mentor MS&T staff, oversee technology transfers into GMP manufacturing, and partner with Manufacturing, Quality, Engineering and Validation to sustain regulatory readiness and robust processes.

Qualifications

• Bachelor's degree with 12+ years, Master's 10+ years, or PhD 8+ years of relevant experience.
• Experience in biopharmaceutical manufacturing.
• Strong expertise in mammalian cell culture and bioreactor systems.

Responsibilities

• Provide technical leadership for investigations, regulatory submissions, and inspections.
• Lead analysis of process verification and manufacturing data to drive improvements.
• Troubleshoot manufacturing issues across internal operations and CMOs.

Skills

Applied Statistics

Change Controls

Data Analytics

GDP Knowledge

GMP

HSE Knowledge

Manufacturing Processes

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process and Cleaning Validation

Process Control

Quality Compliance

Regulatory Compliance

Technical Leadership

Technology Transfer

Education

Bachelor's degree

Master's degree

PhD

Job description

Novartis Group of Companies in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guiding investigations and driving continuous improvement to ensure high-quality, reliable products.

You will mentor MS&T staff, oversee technology transfers into GMP manufacturing, and partner with Manufacturing, Quality, Engineering and Validation to sustain regulatory readiness and robust processes.