Aseptic Drug Product MS&T Lead | Process & Tech Transfer

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

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous PTO

Job summary

Novartis AG in Durham, NC is seeking a Sr. Engineer, Manufacturing Science and Technology - Aseptic Drug Product to lead aseptic manufacturing improvements and support new product introductions. You will drive process performance, partner with cross-functional teams, and ensure high-quality, compliant operations onsite.

You will influence CPV, CQAs/CPPs, and Tech Transfer while guiding continuous improvement projects and remediation efforts across manufacturing, validation, and engineering teams.

Qualifications

• Bachelor’s degree with 6+ years biopharmaceutical manufacturing experience, or Master’s with 4+ years, or Doctorate with 2+ years.
• Experience supporting GMP biopharmaceutical manufacturing operations.
• Hands-on aseptic fill-finish operations and sterile drug product manufacturing.
• Experience with Tech Transfer, process validation, lifecycle management, or manufacturing process improvements.

Responsibilities

• Lead CPV activities by analyzing process data and driving improvements.
• Serve as MS&T technical lead for manufacturing investigations and root cause analysis.
• Partner with Manufacturing to support production schedules and GMP compliance.
• Monitor CQAs and CPPs to ensure product quality and process control.
• Identify, evaluate and implement process improvements for reliability and efficiency.
• Support the introduction of new equipment and processes through startup activities.
• Author and support process change documentation with Engineering and Validation teams.
• Provide technical expertise for remediation efforts and project deliverables.
• Collaborate with Development to execute Tech Transfer and product commercialization.

Skills

Aseptic fill-finish

Process data analysis

GMP compliance

Tech Transfer

Cross-functional collaboration

Education

Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering

Master’s degree

Doctorate degree

Job description

Novartis AG in Durham, NC is seeking a Sr. Engineer, Manufacturing Science and Technology - Aseptic Drug Product to lead aseptic manufacturing improvements and support new product introductions. You will drive process performance, partner with cross-functional teams, and ensure high-quality, compliant operations onsite.

You will influence CPV, CQAs/CPPs, and Tech Transfer while guiding continuous improvement projects and remediation efforts across manufacturing, validation, and engineering teams.