Principal Engineer, MS&T

Job Description Summary

Drive the future of gene therapy manufacturing and make a meaningful impact on patients’ lives. As a Principal Engineer, MS&T, you will serve as a scientific and technical leader for upstream processes, bringing deep expertise in gene therapy manufacturing to support innovation, troubleshoot complex challenges, and continuously elevate product quality. You will play a critical role in shaping manufacturing excellence, leading cross‑functional collaboration, and advancing cutting‑edge technologies to ensure reliable, high‑quality delivery of life‑changing therapies.

This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

• Provide technical leadership and subject matter expertise for complex scientific investigations, regulatory submissions, and inspections.
• Lead the analysis of process verification and manufacturing data to identify trends, assess process performance, and drive data‑driven continuous improvement initiatives.
• Leverage deep expertise in upstream manufacturing processes (including mammalian cell culture and gene therapy platforms) to troubleshoot and resolve complex manufacturing issues across internal operations and external partners (CMOs).
• Mentor and develop MS&T staff, providing technical guidance in upstream processing, including troubleshooting of complex platforms such as triple transfection.
• Lead and support product technology transfers into GMP manufacturing environments, ensuring successful scale‑up, process robustness, and knowledge transfer across receiving sites.
• Partner cross‑functionally with Manufacturing, Quality, Engineering, and Validation teams to ensure reliable execution of production processes and sustained commercial supply.
• Monitor critical quality attributes and process parameters to maintain product consistency.
• Define and implement process improvements with global process owners and operations teams.
• Support the startup, qualification, and lifecycle management of manufacturing equipment, systems, and processes, ensuring compliance with validation and regulatory expectations.
• Author, review, and approve technical documentation (e.g., investigations, change controls, process descriptions) to ensure accuracy, completeness, and regulatory defensibility.
• Drive operational excellence initiatives and collaborate with Quality to ensure regulatory compliance.

• Bachelor’s degree with at least 12 years, Master’s degree with 10 years, or PhD with at least 8 years of relevant experience. OR 9 years of experience with 3+ years of Novartis gene therapy process support.
• Experience in biopharmaceutical manufacturing aligned with the degree and years of experience outlined above.
• Strong expertise in mammalian cell culture and bioreactor systems, both suspension and adherent.
• Demonstrated experience with upstream processing, including triple transfection for gene therapy.
• Deep understanding of GMP requirements and validation principles.
• Proven ability to lead complex technical troubleshooting and manufacturing investigations.
• Strong written and verbal communication skills across cross‑functional teams.
• Experience with technology transfer, process improvement, and operational excellence initiatives.

• Applied Statistics
• Change Controls
• Data Analytics and Digital (Inactive)
• GDP Knowledge (Inactive)
• Good Manufacturing Practices (GMP)
• HSE Knowledge (Inactive)
• Manufacturing Processes
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process and Cleaning Validation (Inactive)
• Process Control
• Quality Compliance
• Regulatory Compliance
• Resilience and Risk Management (Inactive)
• Technical Leadership
• Technology Transfer

Salary range: $126,000 – $234,000 annually (final salary determined based on relevant skills and experience). Compensation includes a performance‑based cash incentive, eligibility for annual equity awards (depending on level), and a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company…