Site Head and VP of Manufacturing

Position Overview

We are looking for a strategic and operational leader to take charge as the Site Head and Vice President of Manufacturing at our radiopharmaceutical production facility located in Richlands, Brisbane. This leadership role entails steering the entire manufacturing operation of Pb-212 radiopharmaceuticals, assuring dependable clinical supply, strict regulatory adherence, and advancing the site’s capabilities toward commercialization readiness.

Key Responsibilities

• Direct and be accountable for all site operations at our Australian TGA-licensed GMP radiopharmaceutical production plant.
• Formulate and execute the site's strategic plan, operating procedures, and policies to underpin clinical advancements, commercialization goals, and corporate objectives.
• Oversee the departments of Manufacturing, Facilities, Supply Chain & Logistics, as well as Health, Safety & Environment.
• Guarantee the safe, compliant, and consistent manufacture and supply of Pb-212 products for clinical trials and future commercial demands.
• Promote operational excellence through performance indicators, risk control, optimization of resources, and continuous process improvements.
• Plan manufacturing capacity, infrastructure upgrades, and readiness initiatives to support pipeline growth, tech transfers, scaling, facility expansion, and commercialization activities.
• Lead clinical supply chain functions including production scheduling, isotope management, inventory control, and distribution logistics to ensure seamless supply.
• Collaborate cross-functionally with Quality, Regulatory Affairs, R&D, CMC, Clinical, Engineering, and Infrastructure departments to meet site and business objectives.
• Maintain compliance with cGMP, TGA, FDA, and other regulatory standards, prepare the site for inspections, and act as the lead site representative during audits.
• Champion a culture focused on safety, quality, responsibility, and ongoing improvement in line with corporate HSE and quality requirements.
• Build and nurture a high-performing leadership team through talent management, coaching, succession planning, and organizational development.
• Ensure robust communication, collaboration, and knowledge-sharing within the site and across the wider manufacturing network.
• Participate in corporate strategic planning, budgeting, forecasting, and business planning to align site initiatives with company objectives.

Experience, Education & Qualifications

• PhD, MSc, or equivalent academic credentials in engineering, pharmaceutical sciences, or a related field.
• A minimum of 10 years in leadership roles overseeing cross-functional teams within cGMP pharmaceutical manufacturing settings.
• In-depth knowledge of regulatory frameworks such as PIC/S and ICH relevant to the manufacturing of parenteral pharmaceuticals.
• Proven track record of scaling manufacturing operations from clinical stages through to commercial production.
• Strong leadership skills paired with the ability to devise operational strategy and manage diverse stakeholders.
• Exceptional communication capabilities and advanced analytical problem-solving skills.
• Experience with just-in-time pharmaceutical delivery systems and setting up phase-appropriate operations supporting product lifecycle management is highly valued.