Principal Engineer, MS&T

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

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time-off

Job summary

Novartis Group of Companies in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guiding investigations and driving continuous improvement to ensure high-quality, reliable products.

You will mentor MS&T staff, oversee technology transfers into GMP manufacturing, and partner with Manufacturing, Quality, Engineering and Validation to sustain regulatory readiness and robust processes.

Qualifications

• Bachelor's degree with 12+ years, Master's 10+ years, or PhD 8+ years of relevant experience.
• Experience in biopharmaceutical manufacturing.
• Strong expertise in mammalian cell culture and bioreactor systems.

Responsibilities

• Provide technical leadership for investigations, regulatory submissions, and inspections.
• Lead analysis of process verification and manufacturing data to drive improvements.
• Troubleshoot manufacturing issues across internal operations and CMOs.

Skills

Applied Statistics

Change Controls

Data Analytics

GDP Knowledge

GMP

HSE Knowledge

Manufacturing Processes

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process and Cleaning Validation

Process Control

Quality Compliance

Regulatory Compliance

Technical Leadership

Technology Transfer

Education

Bachelor's degree

Master's degree

PhD

Job description

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.

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‑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

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 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

Compensation and Benefits

The salary for this position is expected to range between $126,000 and $234,000 annually.

The final salary offered is determined based on factors such as 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. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays and other leaves.

Skills Desired

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

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.