have some exposure to PET (can be college course even)
be comfortable working in an environment that contains radioactive material.
Job Summary
Radiochemist/Chemist to conduct radiolabeling studies to support R&D portfolio of new and existing products. Requirements include technical expertise in optimization and troubleshooting of synthesis processes, interaction with and transfer of radiolabeling methodology to contract manufacturing sites, and competency in use of HPLC, UV, radio-detection, LCMS and iTLC methodology. Handling of positron and gamma radionuclides for small scale radiolabeling experiments and analytical analysis of both research and commercial products is required. Communication with contract research organizations required for external studies using R&D test compounds. Data interpretation, issue resolution as needed and final report writing is also required.
Job Responsibilities
With minimal direction, develops/writes procedures, and documents results in notebook and report formats. Troubleshoots problems with a range of equipment, procedures and, or automated systems. Accurately describes results to internal work groups. Demonstrates experience with >75% of equipment/automation systems (e.g. HPLC, UV, MS, radio-detectors) and authors close-out reports.
Handling of positron and gamma radionuclides (e.g., F18, Cu-64, In-111, Tc-99m)
Contributes to selection and implementation of new systems and experimental design.
Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.
Accurately documents results in established formats. Prepares written reports on all phases of laboratory and/or field experimental work with limited direction. Demonstrates experience in writing technical documents using templates.
Become familiar and utilize Laboratory and Documentation Operations, including: InfoLinx archiving systems, Radionuclide databases, SOP systems, CMC submission document preparation within R&PD, training modules and long-term strategic goals.
Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards.
Strong organizational, presentation and communication skills, both written and verbal.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Education & Qualifications
BS/BA/MS in Chemistry, Pharmaceutics, Engineering or equivalent.
Usually requires a minimum of 2 - 3 years directly related experience with a BS degree or 1-2 years with a Master's degree
Experience working in a GxP environment
Handling of, and/or exposure to, potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
Expertise in the logical design and review of analytical, pharmaceutics and/or validation experiments.
Expertise with GxP documentation requirements. Regulatory requirements: Mastery for job function; intermediate knowledge for extended group functions; basic knowledge for development.