05 Aug
|
AdvanCell
|
Brisbane City
05 Aug
AdvanCell
Brisbane City
We are seeking a Site Head & VP Manufacturing to 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.
Responsibilities
- 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 & Setting (HSE) functions.
- Ensure the protected, 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 inestablishing new sites and implementing phase-appropriate operations aligned to the lifecycle of pipeline programs are desirable.
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📌 Site Head (Brisbane City)
🏢 AdvanCell
📍 Brisbane City