Executive Director, Internal Manufacturing

Job Summary

We are seeking a seasoned and strategic Executive Director of Internal Manufacturing to lead internal GMP manufacturing operations for pharmaceutical drug products. This role is critical to ensuring the consistent, compliant, and high-quality production of drug products in accordance with FDA and global regulatory standards. The ideal candidate brings deep expertise in GMP manufacturing, a strong commitment to operational excellence, and a proven ability to build and lead high-performing teams.

Key Responsibilities

Manufacturing Leadership

• Provide overall leadership and oversight of internal GMP drug product manufacturing operations, ensuring reliable, efficient, and compliant production.

Quality & Compliance

• Uphold rigorous quality standards and ensure full compliance with FDA and global regulatory requirements.
• Partner closely with Quality Assurance and Regulatory Affairs to ensure alignment of CMC activities, regulatory readiness, and continuous improvement initiatives.

Operational Excellence

• Drive continuous improvement initiatives across manufacturing processes, equipment utilization, and operational workflows to enhance productivity, efficiency, and cost effectiveness.

Team Development & Leadership

• Recruit, mentor, and develop a high-performing manufacturing operations organization capable of meeting current and future production demands.
• Foster a strong performance-driven culture aligned with organizational values.

Strategic Planning

• Develop and execute long-term manufacturing strategies aligned with corporate objectives, including capacity planning, technology enhancements, and operational risk mitigation.

Cross-Functional Collaboration

• Collaborate closely with Supply Chain, External Manufacturing, Quality, R&D, and other cross-functional teams to support product launches, lifecycle management, and future pipeline needs.

Budget & Resource Management

• Oversee departmental budgets, capital expenditures, and resource allocation to ensure manufacturing objectives and production targets are met.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline; advanced degree (MS, MBA, or PhD) preferred.
• Minimum of 20 years of experience in pharmaceutical manufacturing, including at least 5 years in a senior leadership role overseeing commercial manufacturing and complex drug product formulations.
• Deep expertise in GMP regulations and pharmaceutical manufacturing operations.
• Proven track record of successfully leading manufacturing organizations across multiple drug modalities.
• Strong strategic, analytical, and decision-making capabilities.
• Excellent leadership, communication, and stakeholder engagement skills.