Objective

• Assist with the synthesis, execution, and optimization of radiolabeling methods for compounds (e.g., PET, SPECT, and alpha emitting isotopes) for use in preclinical and clinical studies.
• Perform analytical testing and support the development and execution of analytical methods to assess the radiochemical purity, stability, and quality of radiolabeled compounds. Learn and contribute to the establishment of critical quality attributes under supervision.
• Support radiolabeling process development and optimization activities, including identification of critical process parameters, and scale-up efforts for clinical production.
• Follow and support compliance with relevant regulations, including GMP, GLP, radiation safety, and company procedures.
• Maintain accurate records of all experiments, procedures, and results. Assist in the preparation of technical reports, study summaries, and supporting documentation for regulatory submissions.
• Work closely with other departments, including Manufacturing, Pharmacology, and Clinical Development, to support the integration of radiochemistry into the drug development process.
• Uphold strict safety standards in handling radioactive materials and participate in the maintenance of radiation safety procedures and protocols.
• Stay abreast of advancements in radiochemistry and radiopharmaceutical development and actively participate in training and professional development opportunities to expand technical expertise.

Education / Experience

• Education: Bachelor’s degree in Radiochemistry, Chemistry, Chemical Engineering, Nuclear Engineering, Nuclear Medicine, Pharmaceutical Sciences, or a related field. Master’s degree preferred.  Equivalent combinations of education and relevant experience will be considered.
• Experience: 1 years of laboratory, manufacturing, or research experience in a scientific environment required. Experience in radiochemistry, radiopharmaceutical development, pharmaceutical manufacturing, analytical chemistry, or related disciplines is a plus.
• Exposure to or willingness to learn the synthesis and handling of radioactive isotopes (e.g., Pb-203, Pb-212, Ga-68, Cu-64, Cu-67 and F-18).
• Experience with or familiarity with analytical techniques such as HPLC, TLC, GC, NMR, mass spectrometry, or related instrumentation is preferred.
• Experience working in a regulated environment (e.g., GMP, GLP, pharmaceutical, biotechnology, medical device, or academic research laboratory) is preferred.
• Experience with automated radiochemistry synthesis modules is desirable but not required.
• Working knowledge of radiopharmaceutical development or a willingness to learn radiopharmaceutical processes and regulatory requirements.

• Foundational understanding of chemistry, radiochemistry, engineering, pharmaceutical sciences, or a related scientific discipline.
• Interest in learning radiolabeling techniques, purification processes, and radiopharmaceutical development.
• Ability to learn and apply radiation safety principles and procedures.
• Effective communication, including writing, speaking and interpersonal communication.
• Strong critical thinking and problem-solving abilities.
• Organizational and time management skills.
• Strong collaboration and teamwork abilities.
• Ability to learn from feedback and work effectively under the guidance of senior scientists and technical staff.
• Basic data analysis and technical documentation skills.
• Ability to maintain accurate laboratory records and follow established procedures.
• Ability to use computers, software and other technology for inventory and communication purposes.
• Willingness to develop knowledge of supply chain, manufacturing, and radiopharmaceutical operations.
• Flexibility to work various shifts as required.
• Flexible and willing to perform other tasks as assigned.
• Ability to lift up to 60 lbs., with or without reasonable accommodation. 

Work Environment

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• May be required to sit or stand for long periods of 8 hours a day while performing duties. 
• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.