Director, Downstream Technical Operations (Biologics)

About the role

Merck Sharp & Dohme (MSD) is looking for an action-oriented Technical Operations Director to lead its Biologics, single-use, multi-product clinical and commercial manufacturing facilities in Dunboyne, Ireland. Reporting to the Executive Director of Biologics Technical Operations, the Director drives technical excellence across Downstream Technical Operations and leads complex, high-impact technology transfers, helping accelerate the commercialization of a growing biologics pipeline.

Key responsibilities

• Lead the Downstream Technical Operations organization and deliver technical expertise across cell banking, clinical manufacturing and commercial operations.
• Oversee technology transfer direction, development and PPQ batch execution, change control and implementation through to regulatory license.
• Ensure clear accountability and flawless execution of new product introductions from a Downstream perspective.
• Identify, assess and resolve technical risks and escalate them promptly to site and above-site stakeholders.
• Own the technical lifecycle of in-line commercial products, driving continuous improvement and process sustainability.
• Champion digital tools and data-driven solutions in downstream operations.
• Contribute to the Dunboyne Technical Operations Leadership Team and its priorities.

Required profile

• B.S., M.S. or Ph.D. in a relevant engineering or scientific discipline.
• At least 9 years of experience in biopharmaceutical manufacturing and/or development, with a focus on scientific and technical leadership.
• Proven experience in biologics drug substance development, technical operations and new product introduction.
• Experience in a GMP environment, including regulatory filings, investigations, quality notifications and CAPA management.
• People leadership skills, with a track record of cross-division collaboration and matrix leadership.

Required skills

• Deep expertise in biologics molecules, downstream processes, process equipment and automation.
• Lean Six Sigma continuous improvement and operational leadership.
• Preferred: current employees apply through the employer's internal application.