Senior Engineer - Tech Transfer & Process Optimization

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

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