Facility Expansion Project
Radiopharma Manufacturer – USA
The Brief
A US-based radiopharmaceutical manufacturer preparing to add a new isotope production line engaged us to support a critical facility expansion project. The business required multiple senior hires across engineering, supply chain, and validation to ensure readiness for GMP production and regulatory milestones. The mandate was to identify leaders who could deliver technical excellence in highly regulated environments while providing the operational flexibility needed to build capacity in a fast-moving, resource-intensive sector.
The Challenge
Compressed timelines were driven by client demand and broader supply-chain constraints affecting key isotopes and manufacturing inputs. The talent need was highly specific: professionals with radiopharma or sterile-injectable backgrounds who could step into leadership roles during an active buildout and balance nuclear medicine know-how with GMP expectations. Few candidates combine experience in commissioning, qualification, and validation with the agility required in a scaling, pre-commercial organisation. Maintaining regulatory compliance while adapting to shifting priorities significantly narrowed the pool.
Our Approach
We designed a coordinated, multi-hire search targeting senior professionals from sterile injectables, nuclear medicine, and radiopharma manufacturers. Candidates were evaluated for experience with facility commissioning and validation protocols, materials/isotope supply planning, and familiarity with regulatory frameworks for radiopharmaceutical production. Searches for engineering, validation, and logistics leaders were run concurrently to enable synchronised onboarding and avoid gaps that could delay the buildout. We prioritised leaders with proven delivery under tight timelines and strong cultural fit for a high-growth, highly regulated environment.
Outcome
Within 120 days, three senior leaders were appointed across engineering, validation, and logistics, providing the capabilities required to complete the expansion on schedule. The new isotope line was commissioned to support clinical supply and regulatory readiness, strengthening delivery reliability and inspection preparedness. The hires increased operational resilience, improved cross-functional coordination, and positioned the organisation to scale in line with anticipated demand in a sector where credible, consistent supply is a defining advantage.
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