Senior Engineer, MS&T - Technology Transfer

Novartis AG; Durham (NC); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Disability benefits

401(k) matching

Paid time off

Job summary

Novartis AG in Durham, NC seeks a Senior MSAT Engineer to lead technology transfer for drug substance processes and support scale-up and commercialization. The role partners across Manufacturing, Quality, and Supply Chain to ensure GMP production, continuous improvement, and introduction of new products at the Durham site.

The successful candidate will bring hands-on tech transfer experience, strong GMP knowledge, and excellent communication skills to drive process performance and solve complex

Qualifications

• Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 2+ years of relevant experience.
• Experience supporting drug substance manufacturing within a biopharmaceutical production environment.
• Hands-on experience leading or supporting technology transfer, process transfer, or commercialization activities.
• Strong knowledge of GMP/cGMP requirements and manufacturing compliance standards.
• Experience with process monitoring, data analysis, and continuous improvement initiatives.
• Ability to troubleshoot manufacturing processes and lead technical investigations.
• Experience collaborating with cross-functional teams including Manufacturing, Quality, and Supply Chain.
• Strong written and verbal communication skills with the ability to influence technical outcomes.

Responsibilities

• Lead technology transfer activities for new drug substance products and manufacturing processes.
• Support process scale-up, commercialization, and GMP readiness for transferred products.
• Serve as the technical lead for process investigations, troubleshooting, and operational challenges.
• Analyze process performance data and implement improvements to enhance reliability and product quality.
• Monitor CQAs and CPPs to maintain process control and reduce variability.
• Partner with Manufacturing, Quality, and Supply Chain to support production goals and product supply.
• Drive continuous improvement initiatives and support implementation of process changes.
• Support startup and qualification activities for new equipment, systems, and manufacturing processes.

Skills

GMP/cGMP

Tech transfer

Data analysis

Cross-functional

Process monitoring

Investigations

Root cause analysis

Communication

Process scale-up

Continuous improvement

Education

Bachelor's degree

Master's degree

PhD

Job description

Job Description Summary

Join Novartis and help bring innovative therapies to patients through successful technology transfer of drug substance manufacturing processes. As a Senior Engineer within MSAT, you will lead technology transfer activities, support process scale-up and commercialization efforts, and partner across Manufacturing, Quality, and Supply Chain to ensure reliable GMP production. This role offers the opportunity to drive process performance, continuous improvement, and the successful introduction of new products at our Durham site.

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:

• Lead technology transfer activities for new drug substance products and manufacturing processes.
• Support process scale-up, commercialization, and GMP readiness for transferred products.
• Serve as the technical lead for process investigations, troubleshooting, and operational challenges.
• Analyze process performance data and implement improvements to enhance reliability and product quality.
• Monitor CQAs and CPPs to maintain process control and reduce variability.
• Partner with Manufacturing, Quality, and Supply Chain to support production goals and product supply.
• Drive continuous improvement initiatives and support implementation of process changes.
• Support startup and qualification activities for new equipment, systems, and manufacturing processes.

Essential Requirements:

• Bachelor's degree with 6+ years, Master's degree with 4+ years, or PhD with 2+ years of relevant experience.
• Experience supporting drug substance manufacturing within a biopharmaceutical production environment.
• Hands-on experience leading or supporting technology transfer, process transfer, or commercialization activities.
• Strong knowledge of GMP/cGMP requirements and manufacturing compliance standards.
• Experience with process monitoring, data analysis, and continuous improvement initiatives.
• Ability to troubleshoot manufacturing processes and lead technical investigations.
• Experience collaborating with cross-functional teams including Manufacturing, Quality, and Supply Chain.
• Strong written and verbal communication skills with the ability to influence technical outcomes.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $114,100 and $211,900 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 benefits. In 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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

• Applied Statistics
• Change Controls
• Cleaning Validations
• Data Analytics
• Emotional Resilience
• Good Documentation Practices
• Health, Safety, and Environment (HSE) Policy
• Manufacturing Processes
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process Control
• Process Validation
• Quality Compliance
• Regulatory Compliance
• Risk Management
• Technical Leadership
• Technology Transfer