Hiring: Principal Engineer, MS&T Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-12 10:21:06 Employment Type: On-site Target Skills & Keywords : Regulatory Compliance About the job Experience: •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. •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. •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. Required Skills: •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 Qualifications: •Strong expertise in mammalian cell culture and bioreactor systems, both suspension and adherent •Demonstrated experience with upstream processing, including triple transfection for gene therapy •Comprehensive expertise in 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 •Novartis Compensation And Benefit Summary •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 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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!