Senior Director, CMC and Manufacturing

Role: Senior Director of CMC and Manufacturing overseeing commercial drug substance and drug product operations, lifecycle management, and external manufacturing to ensure supply continuity and market readiness. Responsibilities: lead integrated CMC and manufacturing strategies, provide technical oversight of process validation, control strategies, and process improvements; govern relationships with CDMOs/CMOs, manage regulatory CMC content, and ensure compliance; oversee supply chain, demand planning, and risk mitigation; and manage budgets and external partnerships. Requirements: Ph.D. or Master’s in chemical engineering, pharmaceutical sciences, chemistry, or biochemistry; 12+ years in pharma/biotech manufacturing with leadership in commercial product supply, process validation, lifecycle management, and regulatory submissions; proven experience with oligonucleotides or complex biologics preferred. High-Value: extensive knowledge of sterile cGMP manufacturing, global CMC regulatory compliance, and supply chain management; experience with launch readiness, process validation, post-approval changes, and external manufacturing networks. WorkSetup: primarily on-site in Parsippany, NJ, with occasional in-person meetings; location preference on the East Coast.