Executive Director External Manufacturing, Drug Product

We are currently looking to fill an Executive Director of External Manufacturing, Drug Product. In this role you will lead and oversee all aspects of global drug product manufacturing operations managed through external contract manufacturing organizations (CMOs). This role is critical in ensuring the seamless production, quality, and delivery of clinical and commercial products, aligning with company goals and regulatory standards. The ideal candidate will possess deep expertise in biopharmaceutical manufacturing, strategic leadership, and a strong ability to manage complex global operations.

In this role, a typical day may include the following:

• 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.

This role may be a fit for you if you:

• Can negotiate contracts, master service agreements, and supply agreements with CMOs.

• Can build and maintain strong relationships with external partners to ensure mutual success.

• Are able to monitor vendor performance metrics and implement corrective actions, as needed.

• Have the ability to lead and mentor a global team of professionals responsible for external manufacturing operations.

• Can foster a culture of collaboration, accountability, and excellence within the team.

• Can develop and manage budgets for external manufacturing operations.

To be considered for this role you must hold a Bachelor’s degree in Engineering, life sciences or a related field; advanced degree (MBA, MS, or PhD) preferred, and the following amount of relevant experience:

• 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.

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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassi