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Full-time
postgraduate degree
Posted 42d ago
~40 hrs/week
Responsibilities
The Site Head and VP of Manufacturing is responsible for the operational leadership, performance, and scalability of radiopharmaceutical manufacturing operations. This role oversees manufacturing, facilities, supply chain, and technical services to ensure regulatory compliance and successful commercialization.
Requirements
Candidates must hold a PhD, MSc, or equivalent degree in engineering or pharmaceutical sciences. A minimum of 10 years of cross-functional leadership experience in cGMP pharmaceutical manufacturing is required.
Full job description
We are seeking a Site Head & VP Manufacturingto be responsible for the operational leadership, performance, and scalability of the company’s radiopharmaceutical manufacturing operations in Richlands, Brisbane, Australia.
You will oversee the manufacture and supply of Pb-212 radiopharmaceuticals, ensuring reliable clinical supply, regulatory compliance, operational excellence, and readiness for future commercialization.
Working within the company’s global technical and manufacturing strategy, you will translate strategic objectives into scalable manufacturing capabilities and deliver operational alignment, supply reliability, and continuous improvement across site operations. You will provide leadership for Manufacturing, Facilities, Supply Chain & Logistics, Health & Safety, and Technical Services.
This role is responsible for overall site performance to drive compliance, resource optimization, and organizational effectiveness to support sustained growth and business objectives. You will balance day-to-day operational tasks with strategic site leadership, partnering closely with R&D, Quality, CMC, and Clinical teams to advance the site’s technical agenda and support the successful execution of the company’s development and commercialization goals.
\nResponsibilities
Provide leadership and accountability for site operations, manufacturing performance, and organizational effectiveness at the Australian TGA-licensed GMP radiopharmaceutical manufacturing facility in Richlands.
Lead the development and execution of site strategy, operating systems, policies, and objectives to support clinical development, commercial readiness, and corporate goals.
Lead the Manufacturing, Facilities, Supply Chain & Logistics, Health, Safety & Environment (HSE) functions.
Ensure the safe, compliant, and reliable manufacture and supply of Pb-212 radiopharmaceutical products to support clinical trials, pipeline development, and future commercial demand.
Drive operational excellence through KPIs, risk management, resource optimization, and continuous improvement initiatives that enhance efficiency, reliability, and process robustness.
Develop manufacturing capacity, infrastructure, and operational readiness plans to support pipeline growth, technology transfers, scale-up activities, facility expansion, and commercialization.
Lead clinical supply planning and execution, including production scheduling, isotope availability, inventory management, and distribution logistics to ensure uninterrupted product supply.
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.
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.
Foster a strong culture of safety, quality, accountability, and continuous improvement, ensuring adherence to all corporate and site HSE and quality standards.
Build, lead, and develop a high-performing leadership team and workforce through effective talent management, coaching, succession planning, and organizational development.
Establish and maintain effective communication, collaboration, and knowledge-sharing practices across the site and broader manufacturing network.
Contribute to corporate strategy, budgeting, forecasting, and business planning activities to ensure alignment between site operations and organizational objectives.
Experience, Education & Qualifications
PhD, MSc, or equivalent degree in engineering, pharmaceutical sciences or relevant discipline.
Minimum of 10+ years of experience in cross-functional leadership roles within cGMP pharmaceutical manufacturing organisations.
Sound understanding of regulatory requirements and guidelines governing cGMP manufacture of parenteral pharmaceuticals (e.g. PIC/S, ICH).
Experience scaling site operations from clinical to commercial environments.
Strong leadership, operational strategy and stakeholder management capabilities.
Excellent communication skills and strong analytical problem-solving skills.
Experience with just-in-time delivery of medicines and in establishing new sites and implementing phase-appropriate operations aligned to the lifecycle of pipeline programs are desirable.
AdvanCell is a clinical stage radiopharmaceutical company developing an innovative pipeline of 212Pb-based Targeted Alpha Therapies for cancer patients. AdvanCell’s platform technology addresses the most significant challenge in Targeted Alpha Therapy – the reliable and scalable supply of isotope. AdvanCell’s novel drug discovery, preclinical processes, and state-of-the-art facilities leverage daily access to 212Pb, the ideal isotope for Targeted Alpha Therapy. For more information, please visit www.advancell.com.au
Offices: Boston , Massachusetts, US · 9-19 MacGregor Pl, Richlands, Queensland 4077, AU · Level 7, 167 Macquarie Street, Sydney, New South Wales 2000, AU · University of Newcastle, Newcastle, NSW, AU · Queensland Centre for Advanced Technologies, Pullenvale, AU
RadiopharmaceuticalsRadioligand Discovery212PbBiotechnologyBiopharmaceuticalsand Changing the Course of Cancer
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