Senior Manager, CMC Radiopharmaceuticals

The Senior Manager, CMC, Radiopharmaceuticals (RPT) will be working on CMC aspects for SK Life Science Inc.’s RPT drug candidates including but not limited to Ac225, In 111, Ga, Lu etc. This candidate will need to be technically proficient in radiopharmaceuticals and radiometal chemistry and have radiopharmaceutical development analytical expertise as well as CMC writing.

• Selection of CDMO. Establish a comprehensive technical process for RPT drug candidates to facilitate the transfer and management of a productive manufacturing process to CDMO/s. Identification and implementation of appropriate manufacturing and quality control procedures, equipment, and facilities.
• Organize, manage, execute technology transfer to CDMOs.
• Review manufacturing and analytical technical documents (batch records, CoA, specifications, protocols and reports) from CDMO for technical and compliance accuracy.
• Guide and decide about selection and qualification of suitable raw materials, packaging components, shippers that conform to regulatory requirements. 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.
• Co-write the dossier for CMC related modules in IND/IMPD/annual report.
• Communicate effectively with all stakeholders, including management, clients, vendors,
• Keep up with the latest technological advancements and market developments in the field of alpha radio ligand therapy development and offer direction to the top management team

• PharmD, PhD in Radio-Chemistry, Chemical Engineering, Radiopharmaceuticals or related fields within life sciences.
• Minimum of 5 years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development.
• Strong technical knowledge and problem-solving skills in formulation, radiolysis, process validation, qualification of synthesis module, analytical methods with the ability to think strategically and communicate effectively with cross-functional colleagues, specifically preclinical and safety stakeholders.
• Familiarity with relevant regulations (FDA, EMA), standards, and guidelines, including those relating to quality, safety, and environmental impact.
• Excellent know-how on regulatory requirements related to drug development.
• Familiarity with current US and EU regulatory requirements for therapeutic products.
• Written and verbal fluency in English.