Executive Director External Manufacturing, Drug Product

Role Summary

Executive Director External Manufacturing, Drug Product — lead and oversee all aspects of global drug product manufacturing operations managed through external contract manufacturing organizations (CMOs). Ensure seamless production, quality, and delivery of clinical and commercial products, aligning with company goals and regulatory standards.

Responsibilities

• Develop and execute external manufacturing strategies to support global drug product manufacturing needs.
• Establish long-term partnerships with CMOs to ensure capacity, capability, and compliance with company standards.
• Collaborate with internal stakeholders, including supply chain, quality, regulatory, and R&D teams, to align manufacturing strategies with organizational goals.
• Lead end-to-end management of external drug product manufacturing, including planning, production, and delivery as well as execution of new projects.
• Ensure CMOs meet production timelines, cost targets, and quality standards.
• Drive continuous improvement initiatives across external manufacturing operations to optimize efficiency and cost-effectiveness.
• Ensure all drug product manufacturing processes comply with global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
• Support audits and inspections of CMOs to maintain high-quality standards and regulatory compliance.
• Partner with quality teams to address deviations, CAPAs, and other quality-related issues.

Qualifications

• Required: Bachelor‚Äôs degree in Engineering, life sciences or a related field. Advanced degree (MBA, MS, or PhD) preferred.
• Executive Director level: 15+ years of experience in biopharmaceutical manufacturing, with at least 8 years in a leadership role overseeing manufacturing and a proven track record of managing global manufacturing operations in collaboration with vendors and/or CMOs. Strong understanding of regulatory requirements for biopharmaceutical manufacturing (e.g., GMP, FDA, EMA), cell and gene therapies, and/or sterile manufacturing processes preferred.

Skills

• Ability to negotiate contracts, master service agreements, and supply agreements with CMOs.
• Ability to build and maintain strong relationships with external partners to ensure mutual success.
• Ability to monitor vendor performance metrics and implement corrective actions, as needed.
• Ability to lead and mentor a global team of professionals responsible for external manufacturing operations.
• Fostering a culture of collaboration, accountability, and excellence within the team.
• Developing and managing budgets for external manufacturing operations.

Education

• Bachelor‚Äôs degree in Engineering, life sciences or related field; MBA, MS, or PhD preferred.

Additional Requirements

• Travel: This position may require ~25% international travel to CMO sites and company offices as necessary.