Senior MS&T Engineer - Gene Therapy Upstream

Biopharma Careers; North Carolina; On-site; USD 126,000 - 234,000; Full time

Job summary

Novartis in Durham, NC seeks a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guide investigations, and drive continuous improvement across CMOs and internal sites. You will mentor staff, support tech transfers, and ensure GMP compliance to deliver high-quality therapies at scale.

The role requires deep expertise in mammalian cell culture and bioreactor systems, with strong leadership and cross-functional collaboration.

Qualifications

• Bachelor’s degree with substantial relevant experience or higher degrees as listed.
• Experience in biopharmaceutical upstream manufacturing and gene therapy.
• Strong knowledge of GMP, validation principles, and tech transfers.

Responsibilities

• Provide technical leadership for investigations, regulatory submissions, and inspections.
• Analyze process verification data to identify trends and improve processes.
• Troubleshoot upstream manufacturing issues across internal operations and CMOs.
• Mentor MS&T staff on upstream processing including triple transfection.
• Lead technology transfers to GMP manufacturing environments with scale-up.
• Collaborate with Manufacturing, Quality, Engineering, and Validation teams.

Skills

Mammalian cell culture

Bioreactor systems

Upstream processing

Data-driven problem solving

Education

Bachelor’s degree in a relevant field

Master’s degree

PhD

Tools

GMP knowledge

Process validation

Job description

Novartis in Durham, NC seeks a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guide investigations, and drive continuous improvement across CMOs and internal sites. You will mentor staff, support tech transfers, and ensure GMP compliance to deliver high-quality therapies at scale.

The role requires deep expertise in mammalian cell culture and bioreactor systems, with strong leadership and cross-functional collaboration.