Radiopharmaceutical Scientist

Responsibilities

• Perform radiochemistry research and development for discovery stage programs.
• Develop and validate processes for the manufacture of drug product candidates, including radiosynthesis, purification and formulation according to phase appropriate guidelines.
• Ensure process development methods are designed to meet the phase appropriate release specifications requirements while meeting project timelines.
• Support the development of radiopharmaceutical manufacturing processes to enable the technology transfer to external partner/vendors (CDMOs).
• Set up design of the radiolabelling experiments for manual processes.
• Automate manufacturing processes using automated synthesis units (TRASIS).
• Provide technical expertise as required for the development, trouble shooting on the technology transferred to external vendors/partners.
• Review experimental data both internally and external from vendor/partners. Summarize and interpret results, relaying finding through summary reports, technical documents or presentations.
• Hands on experience with imaging and therapeutic isotopes (ga-68, Pb-212, Lu-177 and Ac-225).
• Hands on experience on radio-HPLC, iTLC, Gamma Counter, HPGe, with operations and troubleshooting knowledge.
• Work closely with cross-functional teams, including analytical development, pre- and non-clinical, and regulatory affairs, to ensure alignment of processes development activities with overall project goals.
• Evaluate, select, and implement new radiolabelling and other radiochemistry instruments and equipment to enhance the capabilities of the radiochemistry laboratory.
• Stay in-the-know of industry regulations and guidelines related to radiolabelling methods and techniques.
• Implement continuous improvement initiatives to enhance the efficiency and effectiveness of radiolabelling processes.
• 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.
• Identify and implement process improvements to increase efficiency, reduce costs, and enhance the safety and quality of the products and services provided by ARTBIO

Qualifications & Education

• M.Sc./PhD in Radio Chemistry, Chemistry, Formulation Chemistry or a related field.
• Minimum of 3 years of relevant experience in the radiopharmaceutical development in industry. With a proven track record in process development.
• Skilled in the development and optimization of automated radiopharmaceutical production methods.
• Experience working with radioactivity and radioactive sources.
• Knowledge of environmental health and radiation safety and quality control testing of radiopharmaceuticals will be an asset.

Knowledge and Skills

• Skills and experience in use of equipment used in radiochemistry labelling and formulation, especially hot cells, biological safety cabinets, radio Radio HPLC. iTLC, Gamma Counters. Experience with alpha tracers and HPGe is an asset.
• In-depth technical knowledge of radioisotopes used in diagnostics and therapeutics. With problem solving skills.
• Excellent communication skills and the ability to collaborate effectively with cross-functional teams.
• Proven track record in technical and scientific writing.
• Excellent organizational and project management skills, with the ability to prioritize and multitask effectively.
• Knowledge of regulatory requirements for pharmaceuticals (especially radiopharmaceuticals) in US and EU is a bonus.
• Can manage complex situations and are a fast learner.
• Written and verbal fluency in English.
• Position requires to be onsite during the work week.
• Strong desire to be part of a mission-oriented company ARTBIO leading a transformative change in patients through alpha radioligand therapy.
• Position will require to 20% of travel within Europe and abroad in North America, A valid passport and eligible to travel into these countries are required.
• Work well in a fast-paced environment. Will be able to perform other duties as assigned.