Site Head, VP Manufacturing

AdvanCell Isotopes Pty Ltd; City of Brisbane; On-site; AUD 350,000 - 550,000; Full time

Job summary

AdvanCell Isotopes Pty Ltd seeks a Site Head & Vice President, Manufacturing to lead and scale radiopharmaceutical production in Australia. You will drive operations, regulatory compliance, and supply readiness across the site, ensuring performance and expansion aligned with development and commercialization goals.

You will partner with R&D, Regulatory, CMC, and Clinical teams to translate strategy into scalable manufacturing capabilities and a robust, compliant supply chain.

Qualifications

• PhD or MSc in engineering, pharmaceutical sciences or a related field.
• Minimum of 5+ years in cross-functional leadership within pharmaceutical manufacturing.
• Solid understanding of cGMP for parenteral pharmaceuticals (PIC/S, ICH).
• Experience scaling site operations from clinical to commercial.
• Strong leadership, strategy, and stakeholder-management skills.

Responsibilities

• Provide leadership for site operations, manufacturing performance, and organizational effectiveness at the GMP radiopharmaceutical facility.
• Develop and execute site strategy, operating systems, policies, and objectives to support clinical development, commercial readiness, and corporate goals.
• Oversee all site functions including Manufacturing, Technical Services, Facilities, Supply Chain & Logistics, Radiation Safety, HSE, and QA/Regulatory support.
• Ensure safe, compliant, and reliable manufacture and supply of Pb-212 radiopharmaceuticals for trials and future demand.
• Drive continuous improvement via KPI tracking, risk management, and capacity planning to enable pipeline growth.
• Lead clinical supply planning, isotope availability, inventory management, and distribution logistics.
• Collaborate with Quality, Regulatory, R&D, CMC, Clinical, Engineering, and Infrastructure to align objectives with business priorities.
• Maintain ongoing compliance with cGMP, regulatory inspections readiness, and represent site during audits.
• Foster a culture of safety, quality, accountability, and continuous improvement.

Skills

Leadership

Cross-functional leadership

Regulatory compliance

Supply chain & logistics

Strategic planning

Communication

Problem solving

Education

PhD, MSc or equivalent

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.

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.

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.

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.

Key responsibilities

Provide overall leadership and accountability for site operations, manufacturing performance, and organizational effectiveness at the Australian TGA-licensed GMP radiopharmaceutical manufacturing facility.

Lead the development and execution of site strategy, operating systems, policies, and objectives to support clinical development, commercial readiness, and corporate goals.

Oversee all site functions, including Manufacturing, Technical Services, Manufacturing Sciences, Facilities, Supply Chain & Logistics, Radiation Safety, Health, Safety & Environment (HSE), and associated support 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 performance management, 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.

About you

PhD, MSc, or equivalent degree in engineering, pharmaceutical sciences or relevant discipline.

Minimum of 5+ years of experience in cross-functional leadership roles within 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.

Working in a team environment and adhering to principals of diversity and inclusion.

Desirable: Experience in GMP manufacture of radiopharmaceuticals.

Desirable: Experience with just-in-time delivery of medicines.

Desirable: Experience establishing new sites and implementing phase-appropriate operations aligned to the lifecycle of pipeline programs.