Director, Downstream Biologics Operations

MSD

Dunboyne

On-site

EUR 180,000 - 280,000

Full time

2 days ago
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Job summary

MSD in Dunboyne is seeking an action-oriented Technical Operations Director to provide strategic and hands-on downstream leadership for biologics manufacturing, both clinical and commercial. You will drive technical excellence across downstream operations and lead high‑impact technology transfers.

Reporting to the Executive Director of Biologics Technical Operations, you will build and coach high‑performing teams, champion data‑driven improvements, ensure GMP compliance, and shape the site’s

Qualifications

  • BS, MS, or PhD in Engineering or a scientific discipline.
  • Minimum 9 years of biopharmaceutical manufacturing or development with leadership roles.
  • Deep expertise in biologics, downstream manufacturing, equipment, and automation.
  • Experience with biologics drug substance development, tech operations, and tech transfers.
  • Strong communication, presentation, and stakeholder management capabilities.
  • GMP experience including regulatory filings, investigations, quality notifications, and CAPA management.

Responsibilities

  • Provide leadership to Downstream Technical Operations across cell banking, clinical manufacturing, and commercial operations at the Dunboyne site.
  • Oversee technology transfer direction, execution of development and PPQ batches, 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 with timely escalation and transparent communication to stakeholders.
  • Own downstream lifecycle management for in-line products, driving continuous improvement and process robustness.
  • Champion deployment of digital tools and data-driven solutions within downstream operations.
  • Serve as a key member of the Dunboyne Technical Operations Leadership Team and contribute to Tech Ops priorities.

Skills

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

Education

BS, MS or PhD in Engineering or Scientific discipline

Job description

MSD in Dunboyne is seeking an action-oriented Technical Operations Director to provide strategic and hands-on downstream leadership for biologics manufacturing, both clinical and commercial. You will drive technical excellence across downstream operations and lead high‑impact technology transfers.

Reporting to the Executive Director of Biologics Technical Operations, you will build and coach high‑performing teams, champion data‑driven improvements, ensure GMP compliance, and shape the site’s

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