Drug Substance Manufacturing Unit Lead (Assoc. Dir.)

Novartis; Durham (CA); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis in Morrisville, NC is seeking an Associate Director, Manufacturing Unit Head to lead the new Drug Substance site from start-up through commercial production. You will build and coach a high-performing team, drive safety, quality, and regulatory readiness, and shape world-class manufacturing capabilities from the ground up.

The role blends technical leadership with strategic vision: oversee processes, validation, equipment, and operations; champion operational excellence; and collaborate

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.
• Demonstrated 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 operations from facility start-up through commercial production.
• 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

Regulatory readiness

Cross-functional collaboration

Operational excellence

Data-driven decisions

Education

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

Job description

Novartis in Morrisville, NC is seeking an Associate Director, Manufacturing Unit Head to lead the new Drug Substance site from start-up through commercial production. You will build and coach a high-performing team, drive safety, quality, and regulatory readiness, and shape world-class manufacturing capabilities from the ground up.

The role blends technical leadership with strategic vision: oversee processes, validation, equipment, and operations; champion operational excellence; and collaborate