Manufacturing Unit Lead-Drug Substance
$138,600–$257,400 year
On-siteDurham, North Carolina, United States
Job Summary
Lead Drug Substance manufacturing operations from facility start-up through commercial production, serving as the process owner for equipment and systems throughout the project lifecycle. Provide technical leadership for manufacturing processes, validation, and operational readiness while ensuring safe, compliant activities aligned with cGMP requirements. Build and lead a high-performing team, drive inspection readiness for regulatory audits, and manage deviation investigations with root cause analysis and corrective actions. Explore data and technology to support the site's digital transformation journey. This Associate Director level role at Novartis in Morrisville, NC, focuses on establishing world-class manufacturing capabilities from the ground up.
Required 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
Desired Qualifications
- Experience with Active Pharmaceutical Ingredients (API), freeze drying (lyophilization), manufacturing skids, and oligonucleotide manufacturing
- Lean Management, Operational Excellence certification, or comparable qualifications
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