Job Description Summary

The Director, Radiopharma Technical Strategy & Operations will play a pivotal role in providing high-level scientific and technical leadership within the Manufacturing Sciences and Technology (MSAT) team. This position reports directly to the Head of MSAT and is responsible for driving innovation, technical strategy, and process optimization for the radiopharmaceutical manufacturing operations, particularly in the PET radiotracer space. With deep expertise in radiochemistry, process development, and global manufacturing operations, the Senior Director will bridge the gap between research, development, and large-scale production, ensuring operational excellence while providing guidance on the technical aspects of manufacturing processes. Additionally, this role will provide crucial support for business development efforts related to the optimization and utilization of the Arlington Heights facility, with a focus on leveraging equipment and capabilities to explore and expand into the broader radiotherapeutics sector.

Job Description

Roles & Responsibilities:

Technical Leadership and Innovation:

• Provide strategic technical direction in the radiopharmaceutical manufacturing space, focusing on radiochemistry, process development, and cutting-edge technologies that impact production efficiency and product quality.

• Lead the technical strategy for new product development, scalable manufacturing, and advanced radiopharma processes.

• Act as the subject matter expert on radiochemistry, ensuring that scientific advancements and technical innovations are integrated into the company’s manufacturing processes.

• Lead and advise on the development and optimization of radiotracers, ensuring that processes meet both scientific and regulatory standards.

Collaboration with Head of MSAT:

• Partner with the Head of MSAT to align the operational execution of manufacturing with long-term strategic goals, ensuring that innovations in radiopharma manufacturing are seamlessly integrated into daily operations.

• Provide technical expertise to the MSAT team in troubleshooting complex radiochemistry issues, guiding improvements in production processes where technical expertise is required.

• Support the Head of MSAT in problem-solving and decision-making for manufacturing challenges, particularly those that involve technical or scientific barriers.

Business Development Support:

• Collaborate with business development teams to identify and optimize opportunities for utilizing the Arlington Heights facility, ensuring that equipment and manufacturing capabilities are leveraged to expand into the broader radiotherapeutics field.

• Work closely with leadership to develop strategies that align operational and technical capabilities with business development goals, ensuring optimal utilization of existing resources to drive business growth.

• Support business development activities by providing technical assessments, market insights, and innovative strategies for entering new therapeutic areas, particularly in radiotherapeutics, and other emerging sectors.

• Provide strategic input on the development and scale-up of manufacturing processes aimed at supporting commercial entry into new radiotherapeutic markets.

Global Manufacturing & Tech Transfer:

• Help support and oversee global tech transfer activities related to radiopharmaceutical manufacturing, ensuring seamless transitions from research and development to commercial production.

• Provide technical guidance on scaling up production processes at internal and external manufacturing sites, ensuring the technology is successfully integrated into larger-scale operations.

• Collaborate with external partners, including contract manufacturers, radiopharmacies, and CMOs, to ensure high standards in manufacturing processes and product quality.

Operational Excellence and Process Optimization:

• Work with the Head of MSAT to identify opportunities for process optimization, utilizing your technical expertise to suggest innovations that drive efficiency, reduce production costs, and improve overall product yield.

• Support troubleshooting activities for complex technical issues, particularly those related to radiotracer production and advanced manufacturing technologies.

• Act as a key advisor in resolving complex technical problems that may arise during the manufacturing process, guiding the MSAT team in developing corrective actions.

Regulatory Compliance & Risk Management:

• Ensure that radiopharmaceutical manufacturing pr