Senior Engineer, Tech Transfer & Process Excellence

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Onsite in Durham, NC

Competitive compensation

401(k) with company match

Health, life and disability benefits

Generous vacation and leaves

Job summary

Novartis in Durham, NC seeks a Senior MSAT Engineer to lead technology transfer and support scale-up for drug substance manufacturing. You will partner across Manufacturing, Quality, and Supply Chain to ensure GMP production and continuous improvement.

You will drive process performance, troubleshoot technical issues, and support qualification activities for new equipment and processes in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree with 6+ years in drug substance manufacturing or related field.
• Master's degree with 4+ years or PhD with 2+ years of relevant experience.
• Experience supporting technology transfer and process commercialization.
• Strong knowledge of GMP/cGMP requirements and manufacturing compliance.
• Experience with data analysis, process monitoring and improvement initiatives.
• Ability to troubleshoot and lead technical investigations with cross-functional teams.

Responsibilities

• Lead technology transfer activities for new drug substances and processes.
• Support process scale-up, commercialization and GMP readiness.
• Serve as technical lead for investigations and operational challenges.
• Analyze process data and implement improvements to reliability and quality.
• Monitor CQAs and CPPs to maintain process control and reduce variability.
• Collaborate with Manufacturing, Quality and Supply Chain to meet production goals.
• Drive continuous improvement and support equipment startup and qualification.

Skills

Technology transfer

GMP knowledge

Data analysis

Process improvement

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in a relevant field

Master's degree in a related field

PhD in a relevant field

Job description

Novartis in Durham, NC seeks a Senior MSAT Engineer to lead technology transfer and support scale-up for drug substance manufacturing. You will partner across Manufacturing, Quality, and Supply Chain to ensure GMP production and continuous improvement.

You will drive process performance, troubleshoot technical issues, and support qualification activities for new equipment and processes in a fast-paced manufacturing environment.