Manufacturing Unit Lead-Drug Substance

Role: Associate Director - Manufacturing Unit Head for Drug Substance at Novartis, overseeing facility start-up through commercial production to ensure manufacturing excellence, safety, and quality. Responsibilities: lead operations, serve as process owner, provide technical leadership, develop high-performing teams, support regulatory inspections, lead deviation investigations, champion operational excellence, and support digital transformation efforts. Requirements: Bachelor's in Engineering, Chemistry, Biology, or related field; 10+ years in GMP pharma manufacturing; 5+ years of people leadership; experience with quality, compliance, and regulatory audits; strong knowledge of API and Drug Substance processes. Preferred: experience with lyophilization, skids, oligonucleotides; Lean Management or Operational Excellence certifications. HighValue: biologics or API manufacturing, facility startup, cGMP compliance, regulatory readiness, process validation, continuous improvement. WorkSetup: Morrisville, NC; likely onsite with strategic focus on building manufacturing capabilities from ground up.