Senior Scientist, Radiochemistry/Radiopharmacy

Summary

We're seeking a Senior Scientist in Radiochemistry who will be responsible for technically designing, managing, and executing a radiopharmaceutical development and manufacturing plan for Pb212-drug candidates. The successful candidate will support radiolabelling. metal complexation, and formulation for our new radiochemistry platform paradigm focusing on Pb212. This candidate must have a profound understanding of the academic and literature landscape and the ability to integrate learnings and failures from others to improve the radiochemistry processes.

Responsibilities

• Participate and promote a dedicated vision for technical operations, that supports and enhances the company’s Pb212 drug candidate’s long-term plan.
• Establish a manufacturing development plan, execute protocols, and successfully report the development of drug candidates to our CRO/CDMOs, including the identification and implementation of appropriate manufacturing processes and equipment.
• Increase internal technical and operational capabilities to develop the radiochemistry platform focused on Pb212 including continuous monitoring, improvement and troubleshooting in the scope of radioprocess manufacturing, in process control including Radio-QC and release time.
• Support the selection of chelators of Pb212 and the daughters to the candidates.
• Establish and validate a formulation protected from radiolysis allowing target shelf life.
• Develop and execute qualification of material dedicated to our radiochemistry platform including automation of the radiolabeling.
• Develop and maintain relationships with key suppliers and service providers to ensure the reliable and efficient supply of raw materials, equipment, and services.
• Ensure compliance with all relevant regulations, standards, and guidelines, including those relating to quality, safety, and environmental impact for our CDMOs, internal R&D and own projects.
• Communicate effectively with all stakeholders, including senior management, customers, suppliers, and regulators, to ensure that everyone is aligned on the strategic vision and objectives of the company.
• Stay abreast of technological advancements and market trends in the field of alpha radioligand therapy development and provide guidance to the senior management team on how ARTBIO can leverage these trends to enhance its competitive position.

Qualifications & Experience

• PharmD, PhD in Alpha Radiochemistry, Radiopharmaceuticals, or related field.
• Minimum of 5 years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development.
• Demonstrated experience in developing alpha radiopharmaceutical at an early stage in terms of radio synthesis and quality control development.
• Strong technical knowledge and problem-solving skills in radio metal chemistry.
• Program management experience.
• Familiarity with relevant radiopharmaceutical regulations (FDA, EMA), standards, and guidelines
• Excellent know-how on regulatory requirements related to drug development.
• Written and verbal fluency in English.