Aseptic MS&T Engineer – Process Excellence & Tech Transfer

Biopharma Careers; United States; On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, for an onsite role in Durham, NC. You will provide technical leadership, drive process performance, and support the introduction of new products and technologies.

Collaborating with Manufacturing, Quality, Engineering and global partners, you will lead investigations, enable successful tech transfers, and sustain a robust supply of sterile products while upholding GMP and continuous improvement.

Qualifications

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related field.
• 6+ years of biopharmaceutical manufacturing experience; advanced degree preferred.
• Experience in GMP biopharmaceutical manufacturing operations.
• Hands-on aseptic fill-finish operations.
• Tech Transfer, validation, lifecycle management, or manufacturing process improvements.

Responsibilities

• Lead CPV analysis and drive process performance improvements.
• Act as MS&T technical lead for investigations and root cause analysis.
• Support production schedules, GMP compliance, and commercial supply.
• Monitor CQAs and CPPs to ensure product quality.
• Lead process improvements and new equipment introductions.
• Collaborate on Tech Transfer activities for product commercialization.
• Author change control documentation with cross-functional teams.
• Drive OPEX initiatives and continuous improvement.

Skills

Data analysis

Cross-functional collaboration

Technical writing

GMP compliance

Aseptic fill-finish

Tech Transfer

Education

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

Master's degree in relevant field

Doctorate in relevant field

Job description

Novartis is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, for an onsite role in Durham, NC. You will provide technical leadership, drive process performance, and support the introduction of new products and technologies.

Collaborating with Manufacturing, Quality, Engineering and global partners, you will lead investigations, enable successful tech transfers, and sustain a robust supply of sterile products while upholding GMP and continuous improvement.