Senior MS&T Engineer, Aseptic Drug Product - Lead Innovator

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

Benefits offered by this job

Health, life & disability benefits

401(k) with company match

Vacation and personal days

Job summary

Novartis seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead aseptic manufacturing efforts in Durham, NC onsite.

You will provide technical leadership, drive process performance, and support new product introductions to ensure reliable supply of high-quality sterile medicines. You will collaborate across Manufacturing, Quality, Engineering and global partners, lead investigations, optimize CQAs/CPPs, and drive continuous improvement while contributing to

Qualifications

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering or related field with 6+ years biopharmaceutical manufacturing experience; Master's 4+ years; Doctorate 2+ years.
• GMP biopharmaceutical manufacturing experience in a regulated environment.
• Aseptic fill-finish operations and sterile drug product manufacturing experience.

Responsibilities

• Lead CPV activities by analyzing process data and driving performance improvements.
• Serve as MS&T technical lead for investigations, root cause analysis, and issue resolution.
• Support production schedules, commercial supply, and GMP compliance.
• Monitor CQAs and CPPs to ensure product quality and process control.
• Identify and implement process improvements for reliability and efficiency.
• Support technology transfer, startup, and implementation of new equipment and processes.
• Author/process change documentation with engineering, manufacturing, and validation teams.

Skills

Data analysis

Technical writing

Cross-functional collaboration

Leadership

Education

Bachelor's in Biochemistry

Master's degree

Doctorate degree

Job description

Novartis seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead aseptic manufacturing efforts in Durham, NC onsite.

You will provide technical leadership, drive process performance, and support new product introductions to ensure reliable supply of high-quality sterile medicines. You will collaborate across Manufacturing, Quality, Engineering and global partners, lead investigations, optimize CQAs/CPPs, and drive continuous improvement while contributing to