Job Description
The Site Head & Vice President, Manufacturing is responsible for the operational leadership, performance, and scalability of the company's
radiopharmaceutical
manufacturing operations in Australia. The role oversees the manufacture and supply of Pb-212
radiopharmaceuticals,
ensuring reliable clinical supply, regulatory compliance, operational excellence, and readiness for future commercialization.
n
Working within the company's global technical and manufacturing strategy, the Site Head & Vice President, Manufacturing translates strategic objectives into scalable manufacturing capabilities and delivers operational alignment, supply reliability, and continuous improvement across site operations.
n
The role provides leadership for all site functions, including Manufacturing, Facilities, Supply Chain & Logistics, Radiation, Health & Safety, and Technical Services. Responsible for overall site performance, the position drives compliance, resource optimization, and organizational effectiveness to support sustained growth and business objectives.
n
The Site Head & Vice President, Manufacturing balances day-to-day operational oversight with strategic site leadership, partnering closely with R&D;, Regulatory, CMC, and Clinical teams to advance the site's technical agenda and support the successful execution of the company's development and commercialization goals.
n
Key responsibilities
n
Provide overall leadership and accountability for site operations, manufacturing performance, and organizational effectiveness at the Australian TGA-licensed GMP
radiopharmaceutical
manufacturing facility.
n




Lead the development and execution of site strategy, operating systems, policies, and objectives to support clinical development, commercial readiness, and corporate goals.
n
Oversee all site functions, including Manufacturing, Technical Services, Manufacturing Sciences, Facilities, Supply Chain & Logistics, Radiation Safety, Health, Safety & Environment (HSE), and associated support functions.
n
Ensure the safe, compliant, and reliable manufacture and supply of Pb-212
radiopharmaceutical
products to support clinical trials, pipeline development, and future commercial demand.
n
Drive operational excellence through performance management, KPIs, risk management, resource optimization, and continuous improvement initiatives that enhance efficiency, reliability, and process robustness.
n
Develop manufacturing capacity, infrastructure, and operational readiness plans to support pipeline growth, technology transfers, scale-up activities, facility expansion, and commercialization.
n
Lead clinical supply planning and execution, including production scheduling, isotope availability, inventory management, and distribution logistics to ensure uninterrupted product supply.
n
Partner cross-functionally with Quality, Regulatory, R&D;, CMC, Clinical,



Engineering, and Infrastructure teams to deliver site objectives, technical initiatives, and manufacturing strategies aligned with business priorities.
n
Ensure ongoing compliance with cGMP, TGA, FDA, and other applicable regulatory requirements, maintaining inspection readiness and serving as the senior site representative during regulatory inspections and audits.
n
Foster a strong culture of safety, quality, accountability, and continuous improvement, ensuring adherence to all corporate and site HSE and quality standards.
n
About you
n
PhD, MSc, or equivalent degree in engineering, pharmaceutical sciences or relevant discipline.
n
Minimum of 5+ years of experience in cross-functional leadership roles within pharmaceutical manufacturing organisations.
n
Sound understanding of regulatory requirements and guidelines governing cGMP manufacture of parenteral pharmaceuticals (e.g. PIC/S, ICH).
n
Experience scaling site operations from clinical to commercial environments.
n
Strong leadership, operational strategy and stakeholder management capabilities.
n
Excellent communication skills and strong analytical problem-solving skills.
n
Working in a team workplace and adhering to principals of diversity and inclusion.
n
Desirable: Experience in GMP manufacture of
radiopharmaceuticals.
n
Desirable: Experience with just-in-time delivery of medicines.
n
Desirable: Experience establishing new sites and implementing phase-appropriate operations aligned to the lifecycle of pipeline programs.

📌 Site Head, Vp Manufacturing (Queensland)
🏢 AdvanCell Isotopes
📍 Queensland