Principal Engineer, MS&T
Novartis
August 21, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Provide technical leadership and subject matter expertise for complex scientific investigations, regulatory submissions, and inspections.
- Lead analysis of process verification and manufacturing data to identify trends, assess process performance, and drive data-driven continuous improvement.
- Troubleshoot and resolve complex upstream manufacturing issues across internal operations and external partners (CMOs), leveraging expertise in mammalian cell culture and gene therapy platforms.
- Mentor and develop MS&T staff; provide technical guidance in upstream processing, including troubleshooting triple transfection.
- Lead and support product technology transfers into GMP manufacturing environments to ensure successful scale-up, process robustness, and knowledge transfer.
- Partner cross-functionally with Manufacturing, Quality, Engineering, and Validation to ensure reliable execution 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 startup, qualification, and lifecycle management of manufacturing equipment, systems, and processes with validation and regulatory compliance.
- Author, review, and approve technical documentation (e.g., investigations, change controls, process descriptions).
- Drive operational excellence initiatives in collaboration with Quality.
Essential Requirements:
- Bachelor’s (12+ years), Master’s (10+ years), or PhD (8+ years) in relevant experience; OR 9 years with 3+ years of Novartis gene therapy process support.
- Biopharmaceutical manufacturing experience.
- Strong mammalian cell culture and bioreactor systems expertise (suspension and adherent).
- Upstream processing experience, including triple transfection for gene therapy.
- Deep GMP and validation understanding.
- Proven ability to lead complex technical troubleshooting and investigations.
- Strong written and verbal communication skills.
- Experience with technology transfer, process improvement, and operational excellence.
Benefits:
- Salary expected range: $126,000–$234,000 annually.
- Performance-based cash incentive; potential for annual equity awards.
- Comprehensive benefits package (US-based eligible employees) and time-off benefits.
Application Instructions:
- Onsite Durham, NC role; no relocation support—apply only if accessible.
- Provide technical leadership and subject matter expertise for complex scientific investigations, regulatory submissions, and inspections.
- Lead analysis of process verification and manufacturing data to identify trends, assess process performance, and drive data-driven continuous improvement.
- Troubleshoot and resolve complex upstream manufacturing issues across internal operations and external partners (CMOs), leveraging expertise in mammalian cell culture and gene therapy platforms.
- Mentor and develop MS&T staff; provide technical guidance in upstream processing, including troubleshooting triple transfection.
- Lead and support product technology transfers into GMP manufacturing environments to ensure successful scale-up, process robustness, and knowledge transfer.
- Partner cross-functionally with Manufacturing, Quality, Engineering, and Validation to ensure reliable execution 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 startup, qualification, and lifecycle management of manufacturing equipment, systems, and processes with validation and regulatory compliance.
- Author, review, and approve technical documentation (e.g., investigations, change controls, process descriptions).
- Drive operational excellence initiatives in collaboration with Quality.
Essential Requirements:
- Bachelor’s (12+ years), Master’s (10+ years), or PhD (8+ years) in relevant experience; OR 9 years with 3+ years of Novartis gene therapy process support.
- Biopharmaceutical manufacturing experience.
- Strong mammalian cell culture and bioreactor systems expertise (suspension and adherent).
- Upstream processing experience, including triple transfection for gene therapy.
- Deep GMP and validation understanding.
- Proven ability to lead complex technical troubleshooting and investigations.
- Strong written and verbal communication skills.
- Experience with technology transfer, process improvement, and operational excellence.
Benefits:
- Salary expected range: $126,000–$234,000 annually.
- Performance-based cash incentive; potential for annual equity awards.
- Comprehensive benefits package (US-based eligible employees) and time-off benefits.
Application Instructions:
- Onsite Durham, NC role; no relocation support—apply only if accessible.