Principal Engineer, MS&T

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

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.

Location

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.

Key Responsibilities

• 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-functional 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

Essential Requirements

• 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 aboveStrong 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

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between $126,000 and $234,000 annuallyThe final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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