Principal Gene Therapy Upstream Manufacturing Engineer

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

Job summary

Novartis in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing and guide cross‑functional teams in process improvement and technology transfers. This onsite role emphasizes regulatory readiness, investigations, and robust execution across CMOs and internal operations.

You will mentor MS&T staff, oversee complex troubleshooting, and drive lifecycle management of critical equipment to ensure high‑quality, compliant production of gene therapy therapies.

Qualifications

• Bachelor’s degree with 12+ years experience, or Master’s with 10+ years, or PhD with 8+ years.
• Experience in biopharmaceutical manufacturing.
• Strong knowledge of GMP and validation principles.
• Experience leading investigations and technical troubleshooting.

Responsibilities

• Provide technical leadership for complex scientific investigations, regulatory submissions, and inspections.
• Lead the analysis of process verification and manufacturing data to identify trends and drive improvements.
• Leverage expertise in upstream manufacturing processes to troubleshoot issues across operations and CMOs.
• Mentor and develop MS&T staff with guidance in upstream processing including triple transfection.
• Lead technology transfers into GMP manufacturing environments and ensure scale‑up and knowledge transfer.
• Partner with Manufacturing, Quality, Engineering and Validation to ensure reliable production.
• Monitor critical quality attributes and process parameters for product consistency.
• Define and implement process improvements with global process owners and operations teams.
• Support startup, qualification and lifecycle management of equipment and processes with regulatory compliance.
• Author, review and approve technical documentation for investigations and change controls.

Skills

Mammalian cell culture

Bioreactor systems

Upstream processing

Triple transfection

GMP compliance

Data analysis

Regulatory submissions

Troubleshooting

Education

Bachelor’s degree

Master’s degree

PhD

Job description

Novartis in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing and guide cross‑functional teams in process improvement and technology transfers. This onsite role emphasizes regulatory readiness, investigations, and robust execution across CMOs and internal operations.

You will mentor MS&T staff, oversee complex troubleshooting, and drive lifecycle management of critical equipment to ensure high‑quality, compliant production of gene therapy therapies.