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.

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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.

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