Gene Therapy MS&T Principal Engineer – Upstream Leader

NCBiotech; Durham (NC); On-site; USD 126,000 - 234,000; Full time

Job summary

Novartis in Durham, NC, seeks a Principal Engineer, MS&T, to provide scientific and technical leadership for upstream gene therapy manufacturing. This onsite role focuses on process excellence, cross-functional collaboration, and delivering high-quality therapies.

You will mentor staff, support technology transfers, and drive continuous improvement across manufacturing operations. The ideal candidate has deep expertise in mammalian cell culture, upstream processing, and GMP validation, with

Qualifications

• Bachelor’s degree with 12+ years, Master’s with 10+, or PhD with 8+ years of relevant experience.
• Experience in biopharmaceutical manufacturing aligned with the degree and years above.
• Strong expertise in mammalian cell culture and bioreactor systems.
• Demonstrated experience with upstream processing including triple transfection.
• Deep understanding of GMP requirements and validation principles.
• Proven ability to lead complex technical troubleshooting and investigations.

Responsibilities

• Provide technical leadership for scientific investigations, regulatory submissions, and inspections.
• Lead analysis of process verification and manufacturing data to drive improvements.
• Troubleshoot manufacturing issues across internal operations and CMOs.
• Mentor MS&T staff in upstream processing and complex platforms.
• Lead tech transfers into GMP manufacturing with scale-up and knowledge transfer.

Skills

Mammalian cell culture

Bioreactor systems

Upstream processing

Triple transfection

Technical leadership

Education

Bachelor’s degree (12+ years)

Master’s degree (10+ years)

PhD (8+ years)

Tools

Regulatory and GMP knowledge

Job description

Novartis in Durham, NC, seeks a Principal Engineer, MS&T, to provide scientific and technical leadership for upstream gene therapy manufacturing. This onsite role focuses on process excellence, cross-functional collaboration, and delivering high-quality therapies.

You will mentor staff, support technology transfers, and drive continuous improvement across manufacturing operations. The ideal candidate has deep expertise in mammalian cell culture, upstream processing, and GMP validation, with