Executive Director, Internal Manufacturing

Role Summary

Executive Director, Internal Manufacturing — lead internal GMP manufacturing operations for pharmaceutical drug products, ensuring high-quality production in compliance with regulatory standards. Drive operational excellence, build and lead high-performing teams, and develop long-term manufacturing strategies aligned with corporate goals.

Responsibilities

• Manufacturing Leadership: Oversee all aspects of internal GMP drug product manufacturing operations, ensuring consistent, compliant, and efficient production.
• Quality & Compliance: Maintain rigorous quality standards and ensure full compliance with FDA and global regulatory requirements. Partner closely with Quality Assurance and Regulatory Affairs teams to coordinate CMC activities and improvements.
• Operational Excellence: Drive continuous improvement across manufacturing processes, equipment utilization, and workflows to enhance productivity and reduce cost.
• Team Development: Recruit, mentor, and develop a high-performing manufacturing operations team that can meet production demands. Foster a team culture representative of Liquidia’s core values.
• Strategic Planning: Develop and execute long-term manufacturing strategies, including capacity planning, technology upgrades, and risk mitigation.
• Cross-Functional Collaboration: Work with Supply Chain, External Manufacturing, Quality, R&D, and other departments to support product launches and lifecycle management.
• Budget & Resource Management: Manage departmental budgets, capital expenditures, and resource allocation to meet production targets and strategic objectives.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree (MS, MBA, PhD) preferred.
• Minimum of 20 years of experience in pharmaceutical manufacturing, with at least 5 years in a senior leadership role overseeing commercial manufacturing and complex drug product formulation.
• Deep understanding of GMP regulations and pharmaceutical production processes.
• Proven track record of leading successful manufacturing operations and teams for different modalities.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Excellent communication and leadership abilities.

Skills

• GMP manufacturing leadership
• Quality assurance and regulatory compliance
• Operational excellence and process improvement
• Strategic planning and budgeting
• Cross-functional collaboration

Education

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.

Additional Requirements

• Lean Six Sigma or other operational excellence certifications preferred.