Principal Engineer, MS&T

Job Description Summary

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 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
• Author review and approve technical documentation (e.g. investigations change controls process descriptions) to ensure accuracy completeness and regulatory defensibility
• Drive operational excellence initiatives and collaborate with Quality to ensure regulatory compliance

Essential Requirements:

• Bachelors degree with at least 12 years Masters 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
• Deep understanding of 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
• Experience with technology transfer process improvement and operational excellence initiatives

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $126000 and $234000 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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired