Drug Substance Manufacturing Unit Lead – Startup Site

Novartis; Durham (NC); On-site; USD 138,600 - 257,400; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off package

Job summary

Novartis in Morrisville, NC is seeking an Associate Director to launch and scale a state-of-the-art Drug Substance manufacturing site. You will lead the DS operations from facility start-up through commercial production, serve as process owner, and drive zero-defect operations with a focus on safety, quality and regulatory readiness.

You will build and coach a high-performing team, champion continuous improvement, and collaborate across functions to deliver reliable supply for patients while

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline.
• Minimum 10 years of pharmaceutical or life sciences manufacturing experience in GMP environment.
• Minimum 5 years of people leadership experience managing manufacturing operations and developing high-performing teams.
• Experience leading quality, compliance, inspection readiness, and regulatory audit activities.
• Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and commercial operations.
• Proven ability to drive operational excellence, continuous improvement, and cross-functional collaboration in a regulated environment.

Responsibilities

• Lead Drug Substance manufacturing from start-up through commercial production.
• Serve as process owner for DS manufacturing, equipment and systems throughout the project lifecycle.
• Provide technical leadership for manufacturing processes, equipment, validation, and operational readiness activities.
• Ensure safe, compliant, and reliable manufacturing operations aligned with cGMP requirements.
• Build, lead, coach, and develop a high-performing manufacturing team while maintaining training compliance.
• Drive inspection readiness and support successful regulatory inspections, audits, and compliance activities.
• Lead deviation investigations, root cause analysis, and implementation of effective CAPAs.
• Champion operational excellence initiatives to enhance productivity, process robustness, and manufacturing performance.
• Explore and leverage data and technology to support the site's digital transformation journey.

Skills

People leadership

GMP manufacturing

Regulatory compliance

Process ownership

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline

Job description

Novartis in Morrisville, NC is seeking an Associate Director to launch and scale a state-of-the-art Drug Substance manufacturing site. You will lead the DS operations from facility start-up through commercial production, serve as process owner, and drive zero-defect operations with a focus on safety, quality and regulatory readiness.

You will build and coach a high-performing team, champion continuous improvement, and collaborate across functions to deliver reliable supply for patients while