Principal Engineer, MS&T

Job Description SummaryDrive 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.Job DescriptionLocation: 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 inspectionsLead the analysis of process verification and manufacturing data to identify trends, assess process performance, and drive data driven continuous improvement initiativesLeverage 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 transfectionLead and support product technology transfers into GMP manufacturing environments, ensuring successful scale-up, process robustness, and knowledge transfer across receiving sitesPartner cross-functionally with Manufacturing, Quality, Engineering, and Validation teams to ensure reliable execution of production processes and sustained commercial supplyMonitor critical quality attributes and process parameters to maintain product consistencyDefine and implement process improvements with global process owners and operations teamsSupport the startup, qualification, and lifecycle management of manufacturing equipment, systems, and processes, ensuring compliance with validation and regulatory expectationsAuthor, review, and approve technical documentation (e.g., investigations, change controls, process descriptions) to ensure accuracy, completeness, and regulatory defensibilityDrive operational excellence initiatives and collaborate with Quality to ensure regulatory complianceEssential 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 adherentDemonstrated experience with upstream processing, including triple transfection for gene therapyDeep understanding of GMP requirements and validation principlesProven ability to lead complex technical troubleshooting and manufacturing investigationsStrong written and verbal communication skills across cross-functional teamsExperience with technology transfer, process improvement, and operational excellence initiativesNovartis 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.#LI-OnsiteEEO 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 accommodationsThe 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 View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Salary Range$126,000.00 - $234,000.00Skills DesiredApplied 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 TransferSummaryLocation: DurhamType: Full time