Challenge
The objective was to deliver a flagship laboratory at a new Biotech greenfield, consolidating several international laboratory activities into a single next-generation environment. The program required aligning building readiness, laboratory deployment, qualification, and compliance within one coherent execution framework.
At project start, the laboratory environment still required completion and stabilization before any deployment or commissioning could begin. Architectural works, utilities, and environmental conditions had to be finalized to reach a controlled state. This created a complex interface between building works, laboratory requirements, and regulatory expectations, within a highly visible program involving global and site leadership, laboratory heads, quality, and support functions.
The project had to be delivered within fixed regulatory timelines, including GMP licensing and inspection readiness with Swissmedic, making execution discipline and coordination critical throughout the program.
Solution
NEVESO assumed end-to-end program leadership as an external Project Lead, embedded within the client’s Project Leadership Team from early 2023. A strong and continuous on-site presence ensured close alignment between planning, execution, and decision-making across all phases of the program.
The engagement started with the completion and stabilization of the laboratory and building environment. NEVESO coordinated with the building architect and engineering partners to finalize architecture, utilities, and environmental conditions, bringing the laboratories to a fully controlled and operational state and enabling the transition to deployment and commissioning.
In parallel, NEVESO built and structured the delivery organization from the ground up, integrating client Subject Matter Experts with selected external specialists. Program governance was established early, covering planning, scheduling, budget and CapEx control, executive reporting, and supplier management. As the project progressed, NEVESO progressively built, staffed, and led a multidisciplinary delivery team of approximately twenty people, evolving with each project phase and supporting deployment, commissioning, qualification, and audit preparation.
Business Impact
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Successful delivery of a Next Generation flagship laboratory program valued at over CHF 10 million
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Operational readiness delivered at scale, with more than 1,000 laboratory instruments brought into operation, including over 200 GMP systems
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Laboratory inaugurated in September 2023, enabling site start-up and operational ramp-up
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Achievement of GMP licensing, following a successful inspection with Swissmedic in November 2023
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Full qualification of all GMP laboratory equipment completed by June 2024, securing long-term compliance and operability
“NEVESO provided the structure, leadership, and on-site presence required to deliver a complex flagship laboratory program with confidence and regulatory alignment”