Associate Director, Drug Substance Manufacturing

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

Job summary

Novartis Group Companies is seeking an Associate Director to lead Drug Substance manufacturing operations from facility startup through commercial production at the Morrisville site in North Carolina. The role serves as process owner for DS manufacturing, equipment, and systems across the project lifecycle.

The candidate will provide technical leadership, ensure cGMP compliance, and build a high-performing team while driving readiness for inspections and regulatory audits.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or related discipline.
• 10+ years of pharmaceutical or life sciences GMP manufacturing experience.
• 5+ years of people leadership in manufacturing operations.
• Experience leading quality, compliance, inspections, and regulatory audits.
• Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and operations.
• Proven ability to drive operational excellence 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 readiness activities.
• Ensure safe, compliant manufacturing operations aligned with cGMP requirements.
• Build, lead, coach, and develop a high-performing manufacturing team with training compliance.
• Drive inspection readiness and support regulatory inspections, audits, and compliance activities.
• Lead deviation investigations, root cause analyses, and CAPA implementation.
• Champion operational excellence initiatives to enhance productivity and manufacturing performance.
• Explore data and technology to support the site's digital transformation journey.

Skills

Data Analytics

Education

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

Job description

Novartis Group Companies is seeking an Associate Director to lead Drug Substance manufacturing operations from facility startup through commercial production at the Morrisville site in North Carolina. The role serves as process owner for DS manufacturing, equipment, and systems across the project lifecycle.

The candidate will provide technical leadership, ensure cGMP compliance, and build a high-performing team while driving readiness for inspections and regulatory audits.