Senior Director, Manufacturing & Supply Chain

Position Summary

The Senior Director of Manufacturing and Supply Chain provides strategic and operational leadership for end-to-end manufacturing and supply chain activities across the product lifecycle. This role is accountable for external manufacturing, technology transfer, clinical and commercial supply, demand and supply planning, inventory management, packaging and labeling, distribution, and continuity of supply. The Senior Director develops and executes phase-appropriate strategies that enable compliant, reliable, and cost-effective supply for clinical studies, regulatory approval, launch, and ongoing commercialization.

The position will be required to attend occasional in person meetings in the Parsippany, NJ office with a strong preference to be located on the East Coast.

The Senior Director will report to the Senior Vice President, Chief Technical Officer.

• Lead the integrated manufacturing and supply chain strategy across clinical development, registration, launch, and commercial lifecycle management
• Provide end-to-end oversight of drug substance and drug product manufacturing, scale-up, technology transfer, process characterization, validation, and ongoing process performance
• Direct and govern contract manufacturers, testing laboratories, raw material suppliers, packaging and labeling vendors, logistics providers, and other external partners; establish expectations and resolve technical, quality, delivery, capacity, and cost issues
• Lead clinical and commercial supply planning and execution, including forecasting, production planning, capacity management, packaging and labeling, inventory strategy, distribution, and launch readiness
• Develop supply-continuity and risk-mitigation strategies, including safety-stock targets, dual sourcing, critical-material monitoring, business continuity, and scenario planning
• Ensure manufacturing and supply operations comply with cGMP requirements, approved regulatory filings, quality agreements, and Company procedures; partner with Quality on deviations, CAPAs, change controls, and inspection readiness
• Establish KPIs and governance forums, analyze operational performance and trends, and drive corrective actions and continuous improvement
• Prepare and manage operating budgets, contracts, project plans, timelines, and resource forecasts for manufacturing and supply chain activities
• Collaborate with Quality, Regulatory Affairs, Clinical Operations, Commercial, Finance & Accounting, Program Management, and other functions to align deliverables with corporate and program objectives
• Identify and communicate technical, operational, regulatory, and supply risks; recommend alternatives and elevate issues with clear impact assessments and mitigation plans
• Lead, develop, and mentor a high-performing team; including workforce planning, hiring, goal setting, coaching, performance management, succession planning, and building organizational capability aligned with business needs

• Enterprise-level strategic thinking with the ability to translate business objectives into practical manufacturing and supply plans
• Extensive knowledge of cGMP, pharmaceutical quality systems, global regulatory expectations, and clinical and commercial supply operations
• Demonstrated success leading external manufacturing networks and complex cross-functional programs in a virtual or outsourced operating model
• Strong business and financial acumen, including budgeting, contract negotiation, capacity planning, cost management, and inventory optimization
• Proven ability to identify risk early, make sound decisions amid ambiguity, and communicate clear recommendations to senior leadership
• Excellent leadership, talent development, collaboration, influencing,…