Drug Substance Manufacturing Unit Lead - Startup Site

NCBiotech; Durham (NC); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis is seeking an Associate Director to lead the Drug Substance manufacturing startup at the Morrisville site, building a world-class operation and a high-performing team. You will drive manufacturing excellence, safety, quality, and reliable supply for patients from startup to commercial production.

The role requires extensive GMP experience, leadership, and cross-functional collaboration to ensure inspection readiness and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor's degree in a relevant scientific field.
• 10+ years of pharmaceutical or life sciences manufacturing experience in GMP environment.
• 5+ years of people leadership in manufacturing.

Responsibilities

• Lead Drug Substance manufacturing 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 per 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 analysis, and CAPA implementation.
• Champion operational excellence initiatives to enhance productivity and process robustness.
• Explore and leverage data and technology to support the site's digital transformation journey.

Skills

People leadership

GMP manufacturing

Regulatory inspections

Drug Substance manufacturing

Operational excellence

Cross-functional collaboration

Education

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

Tools

Process validation

Qualification activities

Job description

Novartis is seeking an Associate Director to lead the Drug Substance manufacturing startup at the Morrisville site, building a world-class operation and a high-performing team. You will drive manufacturing excellence, safety, quality, and reliable supply for patients from startup to commercial production.

The role requires extensive GMP experience, leadership, and cross-functional collaboration to ensure inspection readiness and regulatory compliance in a fast-paced environment.