Director, Downstream Technical Operations (MS&T)

Job Description

A fantastic and highly compelling opportunity has arisen for an action-oriented Technical Operations Director to provide strategic and hands-on downstream technical leadership at our Biologics, single-use, multi-product clinical and commercial manufacturing facilities in Dunboyne.

This role sits at the heart of a rapidly evolving and ambitious site, supporting the delivery of innovative biologics to patients while shaping the future of Downstream manufacturing capability.

Reporting to the Executive Director of Biologics Technical Operations, the Director will be accountable for driving technical excellence across Downstream Technical Operations and for leading complex, high-impact technology transfers at site. The successful candidate will play a pivotal role in accelerating the successful commercialization of a diverse and increasingly complex biologics pipeline, while ensuring the robust, reliable, and compliant manufacture of high-quality biologics products. Through strong scientific leadership, disciplined execution, and effective cross-functional collaboration, this role will significantly influence both near-term delivery and the long-term technical strategy of the Dunboyne site.

Key Responsibilities

Bring energy, expertise, and innovation to guide cross-functional and Integrated Process Teams in delivering world-class Downstream technical execution. Key responsibilities include:

·Provide leadership to the Downstream Technical Operations organization, delivering technical expertise across cell banking, clinical manufacturing, and commercial operations at the Dunboyne site.

·Overseeing or providing technology transfer direction, execution of development and PPQ batches, change control management, and implementation through to regulatory license.

·Ensure clear line-of-sight, accountability, and flawless execution of new product introductions from a Downstream perspective.

·Proactively identify, assess, and resolve technical risks and issues, ensuring timely escalation and transparent communication to site and above-site stakeholders.

·Own Downstream technical lifecycle management for in-line commercial products, driving continuous improvement, robustness, and process sustainability.

·Champion the deployment and effective use of digital tools and data-driven solutions within the state-of-the-art downstream operations.

·Serve as a key member of the Dunboyne Technical Operations Leadership Team, contributing to the development and delivery of Tech Ops priorities.

Qualifications & Experience

·B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.

·A minimum of 9 years’ experience within biopharmaceutical manufacturing and/or development, with a strong emphasis on scientific and technical leadership roles.

·Demonstrated technical excellence with deep expertise in biologics molecules, Downstream manufacturing processes, process equipment, and automation.

·Proven experience in biologics drug substance development, technical operations, and new product introduction.

·Strong communication, presentation, and stakeholder-management capabilities, with the ability to influence at all levels of the organization.

·A track record of effective cross-division collaboration and matrix leadership.

·Experience operating within a GMP manufacturing environment, including regulatory filings, investigations, quality notifications, and CAPA management.

·Demonstrated people leadership skills, with a passion for talent development, succession planning, and building high-performing technical teams.

·Solid business acumen, including an understanding of product lifecycle management, financial stewardship, and the ability to manage multiple complex programs simultaneously.

·A strong sense of urgency, resilience, and change agility, combined with an engaging and motivational leadership style.

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Additional location(s) Compensation Information:

Required Skills:

Biologics, Downstream Operations, Engineering Standards, Lean Six Sigma Continuous Improvement, Operational Leadership, People Leadership, Process Improvements, Strategic Thinking

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/11/2026

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