Principal Engineer, MS&T
Novartis
18 days ago
On-site
Durham, NC
Operations
Role (Onsite): Principal Engineer, MS&T — Durham, NC (onsite). No relocation support.
Key Responsibilities:
- Provide technical leadership for complex scientific investigations, regulatory submissions, and inspections
- Analyze process verification/manufacturing data to identify trends, assess performance, and drive continuous improvement
- Troubleshoot upstream manufacturing issues (mammalian cell culture and gene therapy platforms) with internal teams and external CMOs
- Mentor MS&T staff; guide upstream troubleshooting including triple transfection platforms
- Lead/support technology transfers into GMP manufacturing (scale-up, robustness, knowledge transfer)
- Partner with Manufacturing, Quality, Engineering, and Validation to ensure reliable production and commercial supply
- Monitor critical quality attributes and process parameters for product consistency
- Define and implement process improvements with global process owners/operations
- Support startup, qualification, and lifecycle management of manufacturing equipment/systems/processes with validation/regulatory compliance
- Author/review/approve technical documentation (investigations, change controls, process descriptions)
- Drive operational excellence and support regulatory compliance with Quality
Essential Requirements:
- BS with 12+ years, MS with 10+ years, or PhD with 8+ years relevant experience (OR 9 years experience with 3+ years Novartis gene therapy process support)
- Biopharmaceutical manufacturing experience
- Strong mammalian cell culture and suspension/adherent bioreactor expertise
- Upstream gene therapy experience including triple transfection
- GMP requirements and validation principles
- Lead complex troubleshooting/investigations; strong written/verbal communication
- Experience with technology transfer, process improvement, operational excellence
Compensation/Benefits (explicit): Expected salary $126,000–$234,000; performance-based cash incentive; possible annual equity. US benefits and time off package included.
Key Responsibilities:
- Provide technical leadership for complex scientific investigations, regulatory submissions, and inspections
- Analyze process verification/manufacturing data to identify trends, assess performance, and drive continuous improvement
- Troubleshoot upstream manufacturing issues (mammalian cell culture and gene therapy platforms) with internal teams and external CMOs
- Mentor MS&T staff; guide upstream troubleshooting including triple transfection platforms
- Lead/support technology transfers into GMP manufacturing (scale-up, robustness, knowledge transfer)
- Partner with Manufacturing, Quality, Engineering, and Validation to ensure reliable production and commercial supply
- Monitor critical quality attributes and process parameters for product consistency
- Define and implement process improvements with global process owners/operations
- Support startup, qualification, and lifecycle management of manufacturing equipment/systems/processes with validation/regulatory compliance
- Author/review/approve technical documentation (investigations, change controls, process descriptions)
- Drive operational excellence and support regulatory compliance with Quality
Essential Requirements:
- BS with 12+ years, MS with 10+ years, or PhD with 8+ years relevant experience (OR 9 years experience with 3+ years Novartis gene therapy process support)
- Biopharmaceutical manufacturing experience
- Strong mammalian cell culture and suspension/adherent bioreactor expertise
- Upstream gene therapy experience including triple transfection
- GMP requirements and validation principles
- Lead complex troubleshooting/investigations; strong written/verbal communication
- Experience with technology transfer, process improvement, operational excellence
Compensation/Benefits (explicit): Expected salary $126,000–$234,000; performance-based cash incentive; possible annual equity. US benefits and time off package included.