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Establishing a pharmaceutical manufacturing facility

Establishing a pharmaceutical manufacturing facility

A global pharmaceutical manufacturer engaged Morgan to establish a new $250M mRNA facility in Melbourne — their first in the southern hemisphere. Morgan embedded with senior leadership to navigate stakeholder pressure, build operational readiness, and support executive decision making.

Industry

Manufacturing

Pharmaceutical

Challenge

Navigating complex bio-technical regulatory requirements and cross-functional site dependencies under an aggressive timeline.

Our Service

Support to Project Delivery & Operational Readiness

Achievements

Seamless facility commissioning with 100% regulatory compliance achieved on schedule.

CONTEXT
Moderna signed a contract to establish Australia's first mRNA vaccine manufacturing operation. The Melbourne site would be the first to combine drug substance and drug product manufacturing under one roof, breaking new ground for Moderna globally.

PROBLEM
Moderna were constructing a brand new +$250 million facility in parallel with building an organisation capable of running it. They needed to recruit, stand up business functions, define processes, and navigate a highly regulated environment. All at pace and against an aggressive timeline, with a complex global stakeholders landscape.

WHAT WE DID
Morgan were onboarded within the first 15 employees. We led the operational readiness program to set up Moderna's manufacturing operations, support the facility construction and commission complex equipment. Embedded in the senior leadership team, we worked with directors to design, develop and deliver their functions. Managing the timeline and coordinating across all parts of Moderna's operations, we helped keep everyone aligned on where we were, progress being made, risks and mitigations and key next steps. We also helped the site build trust in the global network, managing global stakeholder reporting, leading global stakeholder workshops and enabling executive decision making.

THE OUTCOME

Established an operating manufacturing business from scratch. Over 100 people joined Moderna's Australian operations, key manufacturing functions were stood up (operations, quality, manufacturing, science and technology, supply chain, EHS, facilities engineering and digital).
Rapidly built the commercial manufacture maturity of complex drug products. Global stakeholders gained confidence in local leadership's ability to deliver.
It wasn't a straightforward path with perfect execution, but it was a resounding success, contributing to the diversity of Australia's economy.
Moderna and Morgan established a trusted relationship.

PROOF

  • Morgan was re-engaged to develop a three year strategy to expand operations at site

  • Moderna Australia recognised as the benchmark for global reporting by the global head of manufacturing

  • Site successfully completed regulatory inspections

  • Performance metrics demonstrated manufacturing capability

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Want to work with us?

Start with a conversation

Let's chat. Tell us about the challenge you're working through — we'll get back to you within 24 hours.