Radiopharma Manufacturing: VP & Site Leader

AdvanCell

Andover (MN)

On-site

USD 325,000 - 400,000

Full time

12 days ago

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Job summary

AdvanCell seeks a Site Head & Vice President, Manufacturing to lead the Andover facility's radiopharmaceutical manufacturing operations, ensuring reliable clinical supply, regulatory compliance, and scalable capacity for future commercialization.

You will drive strategy, oversee Manufacturing, Facilities, Supply Chain, and Safety, and partner with Quality, R&D, and Regulatory teams to advance the company's development and commercialization goals.

Qualifications

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.

Responsibilities

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.