Principal Engineer, MS&T

Novartis • Durham, CA

3d • $126,000 - $234,000 • Onsite

About The Position

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.

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

Nice To Haves

• Applied Statistics
• Change Control
• Data Analytics and Digital
• GDP Knowledge
• gmp knowledge
• HSE Knowledge
• Manufacturing Process
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process and Cleaning Validation
• Process Control
• Quality Compliance
• Regulatory Compliance
• Resilience and Risk Management
• Technical Leadership
• Technology Transfer

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

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Principal