US Site Head and VP, Manufacturing

Summary    

The Site Head & Vice President, Manufacturing is responsible for the operational leadership, performance, and scalability of the company’s radiopharmaceutical manufacturing operations at the Andover, Massachusetts site. 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 Quality, 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 & Duties

• Provide overall leadership and accountability for site operations, manufacturing performance, and organizational effectiveness at the Andover 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, FDA, NRC 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.
• Champion the company’s mission, values, and culture, creating an engaged, high-performing workplace that supports innovation, growth, and operational excellence.

Essential Skills, Qualifications, Industry and Educational Requirements

• 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 Skills, Qualifications, Industry and Educational Requirements

• Experience in GMP manufacture of radiopharmaceuticals.
• Experience with just-in-time delivery of medicines.
• Experience establishing new sites and implementing phase-appropriate operations aligned to the lifecycle of pipeline programs. 

Founded in 2019, and headquartered in Australia, AdvanCell is a clinical-stage radiopharmaceutical company developing a revolutionary cancer treatment called Targeted Alpha Therapy, providing new hope for patients with untreatable cancers. AdvanCell’s pipeline is powered by innovative technology and a novel approach that ensures a reliable and scalable supply of alpha therapies to drive clinical development and guarantee commercial-scale supply. For more information: https://www.advancell.com.au/

AdvanCell is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.