Novartis
gene therapy manufacturing
PrincipalEngineer,MS&T
Neural analysis suggests this role is
optimal for Principal candidates.
“Principal Engineer, MS&T at Novartis. Skills: gene therapy manufacturing, upstream processes, mammalian cell culture, bioreactor systems, triple transfection, technical leadership, GMP, validation, technology transfer. Serve as a scientific and technical leader for upstream processes. Support innovation, troubleshoot complex challenges, and continuously elevate product quality”
What You'll Achieve.
make a meaningful impact on patients’ lives; continuously elevate product quality; shaping manufacturing excellence; ensure reliable, high-quality delivery of life-changing therapies; identify trends; assess process performance; drive data driven continuous improvement initiatives; ensure successful scale-up, process robustness, and knowledge transfer across receiving sites; ensure reliable execution of production processes and sustained commercial supply; maintain product consistency; ensure compliance with validation and regulatory expectations; ensure accuracy, completeness, and regulatory defensibility; ensure regulatory compliance
Industry & Context.
troubleshoot complex challenges; Lead the analysis of process verification and manufacturing data to identify trends, assess process performance, and drive data driven continuous improvement initiatives; troubleshoot and resolve complex manufacturing issues; troubleshooting of complex platforms such as triple transfection; Proven ability to lead complex technical troubleshooting and manufacturing investigations
onsite role, Novartis is unable to offer relocation support for this role
What They're Looking For.
Must Have
Bachelor's degree with at least 12 years, Master's degree with 10 years, or PhD with at least 8 years of relevant experience, 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, 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, written and verbal communication skills across cross-functional teams, Experience with technology transfer, process improvement, and operational excellence initiatives
Nice to Have
Knowledge of Applied Statistics, Knowledge of Change Control, Knowledge of Data Analytics and Digital, Knowledge of GDP, Knowledge of GMP, Knowledge of HSE, Knowledge of Manufacturing Process, Knowledge of Manufacturing Production, Knowledge of Manufacturing Technologies, Knowledge of Operational Excellence, Knowledge of Process and Cleaning Validation, Knowledge of Process Control, Knowledge of Quality Compliance, Knowledge of Regulatory Compliance, Knowledge of Resilience and Risk Management, Knowledge of Technical Leadership, Knowledge of Technology Transfer
What You'll Do.
Serve as a scientific and technical leader for upstream processes
troubleshoot complex challenges
and continuously elevate product quality
Shape manufacturing excellence
Lead cross-functional collaboration
Advance cutting-edge technologies
Provide technical leadership and subject matter expertise for complex scientific investigations
regulatory submissions
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
and knowledge transfer across receiving sites
Partner cross-functionally with Manufacturing
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
and lifecycle management of manufacturing equipment
ensuring compliance with validation and regulatory expectations
and approve technical documentation (e. g.
process descriptions) to ensure accuracy
and regulatory defensibility
Drive operational excellence initiatives and collaborate with Quality to ensure regulatory compliance
How You'll Work.
Team & Collaboration
Lead cross-functional collaboration; Partner cross-functionally with Manufacturing, Quality, Engineering, and Validation teams; written and verbal communication skills across cross-functional teams
Communication Scope
written and verbal communication skills across cross-functional teams
Process & Methodology
technology transfer, process improvement, operational excellence initiatives
Full Job Description
**Band** Level 4 **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. **Job Description** **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
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