Novartis

Novartis

Principal Engineer, MS&T

Durham · Principal

No sponsorshipDetected 14 days ago
Data AnalysisStatisticsComplianceProcess ImprovementGMPCRISPRCell CultureLeadershipCommunicationCollaboration

About the role

  • 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.
  • Novartis may change the published salary range based on company and market factors.
  • In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers.

Responsibilities

  • 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 to maintain product consistency
  • Define and implement process improvements with global process owners and operations teams
  • Support the startup, qualification, and lifecycle management of manufacturing equipment, systems, and processes, ensuring compliance with validation and regulatory expectations
  • Drive operational excellence initiatives and collaborate with Quality to ensure regulatory compliance
  • Proven ability to lead complex technical troubleshooting and manufacturing investigations

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 above
  • Strong expertise in mammalian cell culture and bioreactor systems, both suspension and adherent
  • Demonstrated experience with upstream processing, including triple transfection for gene therapy
  • Experience with technology transfer, process improvement, and operational excellence initiatives

Skills

  • Job Description Summary

Compensation

  • $126,000.00 - $234,000.00
  • 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.

Benefits

  • Novartis Compensation and Benefit Summary:
  • 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.

Equal opportunity

  • The Novartis Group of Companies are Equal Opportunity Employers.
  • Accessibility and reasonable accommodations
  • The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
  • Please include the job requisition number in your message.
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This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.