Aseptic Drug Product MS&T Engineer — Process Leader

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

Job summary

Novartis in Durham, NC seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead technical initiatives across aseptic manufacturing and tech transfer.

You will partner with Manufacturing, Quality, Engineering, and global teams to drive process performance, support new products, and ensure reliable, high-quality aseptic products for patients. You will apply data-driven approaches to CQAs/CPPs, lead investigations, and advance continuous improvement while ensuring

Qualifications

• Bachelor’s degree with 6+ years biopharmaceutical manufacturing experience; Master’s 4+ years; Doctorate 2+ years.
• GMP biopharmaceutical manufacturing operations experience.
• Hands-on aseptic fill-finish operations and sterile drug product manufacturing.
• Experience with Tech Transfer, process validation, lifecycle management.
• Knowledge of global GMP regulations and quality compliance expectations.

Responsibilities

• Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
• Serve as MS&T technical lead for manufacturing investigations and root cause analysis.
• Support production schedules, commercial supply, and GMP compliance.
• Monitor and trend CQAs and CPPs to ensure product quality and process control.
• Identify and implement process improvements to enhance reliability, efficiency, and performance.
• Support introduction of new equipment, systems, and processes through startup activities.
• Author/update process change documentation with Engineering, Manufacturing, and Validation teams.
• Provide technical expertise for remediation efforts, project deliverables, and technical assessments.
• Collaborate with Development and site partners to execute Tech Transfer and product commercialization.
• Drive OPEX initiatives and foster continuous improvement and manufacturing excellence.

Skills

Data analytics

Change controls

Process validation

Technical leadership

Team collaboration

GMP compliance

Statistical analysis

Education

Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related field

Master’s degree (4+ years experience)

Doctorate (2+ years experience)

Job description

Novartis in Durham, NC seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead technical initiatives across aseptic manufacturing and tech transfer.

You will partner with Manufacturing, Quality, Engineering, and global teams to drive process performance, support new products, and ensure reliable, high-quality aseptic products for patients. You will apply data-driven approaches to CQAs/CPPs, lead investigations, and advance continuous improvement while ensuring