Aseptic Drug Product MS&T Lead

Novartis • Durham, CA

3d • $138,600 - $257,400 • Onsite

About The Position

Imagine leading the science and technology that helps bring life-changing therapies to patients around the world. As the Aseptic Drug Product MS&T Lead, you will play a critical leadership role at our Durham site, driving manufacturing excellence across clinical and commercial aseptic drug product operations. You will lead a talented team of scientists and engineers, oversee process validation and continuous improvement initiatives, and partner across functions to ensure reliable, compliant, and efficient manufacturing. This is an opportunity to shape manufacturing strategy, influence product quality, and make a meaningful impact on patients while helping advance the future of healthcare at Novartis.

Requirements

• Bachelor of Science degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with at least 10 years of aseptic biopharmaceutical manufacturing experience, or a Master of Science degree in a relevant scientific or engineering discipline with at least 9 years of aseptic biopharmaceutical manufacturing experience.
• Proven experience leading and developing high-performing technical teams.
• Strong expertise in aseptic filling operations and pharmaceutical manufacturing processes.
• Demonstrated knowledge of process validation, aseptic validation, and Continued Process Verification activities.
• Understanding of global regulations governing pharmaceutical manufacturing, qualification, and validation requirements.
• Experience managing complex technical projects and cross-functional initiatives.
• Excellent written and verbal communication skills with the ability to influence diverse stakeholders.

Responsibilities

• Lead and optimize aseptic drug product manufacturing processes to ensure quality, compliance, and operational performance.
• Build, develop, and inspire a high-performing team of scientists and engineers.
• Drive technical transfers, process scale-up activities, and lifecycle process management.
• Oversee process validation, aseptic validation, Continued Process Verification, and supporting validation studies.
• Monitor manufacturing data, trends, and reports to maintain regulatory compliance and process robustness.
• Partner with Manufacturing to support production schedules and ensure reliable product supply.
• Serve as the technical lead for process-related challenges and scientific discussions with internal and external stakeholders.
• Collaborate with Regulatory Affairs to support product submissions and inspections.
• Lead cross-functional investigations, identify root causes, and implement effective corrective and preventive actions.
• Champion continuous improvement initiatives that enhance product quality, efficiency, and manufacturing excellence.

Benefits

• health
• life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior