Associate Director, Downstream Technical Operations Lead

Job Description

Join our state-of-the-art biologics manufacturing facility in Dunboyne as the Downstream Technical Operations Lead.

In this pivotal role, you will hold end-to-end technical, manufacturing, and people accountability for a complex, growing biologics program. Reporting directly to the Downstream Technical Operations Director as part of the MSAT function, you will lead a high-performing team of scientists and engineers delivering day-to-day manufacturing support across all downstream unit operations — including chromatography, filtration, and formulation.

What You Will Do

Technical Program Ownership

• Maintain end-to-end technical ownership of the assigned biologics program, guiding activities from technology transfer and PPQ execution through to commercial lifecycle management.

• Act as a core member of the Downstream technical leadership team, helping to shape the site's overall technical strategy and execution standards.

Manufacturing Support & Operational Excellence

• Enable robust, compliant, and reliable production by providing visible, floor-based technical support to resolve real-time manufacturing issues.

• Set clear priorities, expectations, and decision-making frameworks to ensure rapid deviation investigations, root-cause analyses, and change implementation.

• Proactively identify, assess, and resolve manufacturing risks, establishing strong escalation practices and transparent communication with site and global stakeholders.

People Leadership & Talent Development

• Lead, coach, and develop a team of downstream scientists, engineers, SMEs, and subteam leads, ensuring clear accountabilities, capacity management, and strong engagement.

• Foster a culture of continuous learning, scientific rigor, engineering excellence, psychological safety, and lean-driven improvement.

• Mentor team members through complex problem-solving, stretch assignments, and subteam leadership opportunities to strengthen site succession plans.

Cross-Functional Collaboration

• Collaborate closely with Downstream Receiving Unit lead, Integrated Process Teams, Commercialisation partners, and the Global Biologics Organisation to align technical priorities, share best practice, and accelerate the successful delivery of a complex and evolving pipeline. 

• Partner closely at the interface between Development, Quality, Engineering, Automation, Supply Chain, and global technical partners to drive strategic program delivery.

What Skills You Will Need

Education & Professional Experience

• Degree: B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.

• Experience: A minimum of 8-10 years of experience in biopharmaceutical manufacturing and/or development, with a proven track record in scientific and technical leadership roles.

Technical & Operational Expertise

• Downstream Processes: Deep technical expertise in biologics molecules, chromatography, filtration, formulation, process equipment, and automation.

• Product Lifecycle: Proven experience in biologics drug substance development, downstream technical operations, technology transfer, PPQ, and new product introduction.

• GMP Compliance: Strong operational experience in a highly regulated GMP environment, including floor-based support, regulatory filings, investigations, quality notifications, CAPA management, and process monitoring.

• Business Acumen: Solid understanding of product lifecycle management, financial stewardship, and the ability to manage resource allocation across multiple complex programs simultaneously.

Leadership & Influence

• Leading Through Others: Proven ability to build, scale, and lead high-performing technical teams, setting clear priorities and coaching technical decision-making.

• Stakeholder Management: Excellent communication and presentation capabilities, with a demonstrated ability to influence and collaborate across all levels of a global network.

• Agility & Drive: A strong sense of urgency, resilience, and change agility, combined with an engaging, motivational leadership style.

Why Join Us?

• Work in a cutting-edge, state-of-the-art biologics facility in Dunboyne.

• Lead a diverse, growing pipeline of biologics programs.

• Drive technical excellence within a highly collaborative, cross-functional global network.

Required Skills:

Business Acumen, Business Acumen, Business Management, Change Adoption, Chromatography, Computerized Maintenance Management Systems (CMMS), Cross-Cultural Awareness, Deviation Investigations, Financial Management, GMP Compliance, GMP Environments, Maintenance Supervision, Manufacturing Quality Control, Manufacturing Support, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Product Lifecycle, Regulatory Compliance, Regulatory Inspections, Resource Allocation, Single-Use Systems (SUS), Sterile Manufacturing, Strategic Thinking {+ 1 more}

Preferred Skills:

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/20/2026

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