Ionetix is seeking a Production Radiochemist in Lansing, MI to perform aseptic manufacturing of radioisotopes of Actinium-225 and Astatine-211.

Ionetix is a growing company, with revolutionary cyclotron technology. We have full isotope production and processing, drug manufacturing, and distribution logistics. Our staff enjoy an excellent benefits package including a competitive salary, generous retirement plan, stock options, over 6 weeks of paid time off per year to start, and health insurance begins on your first day of employment.

Consider applying for this new role as we expand our business, where you have the opportunity to:

  1. Prepare radioisotope quality control samples and dispense radioisotope for customer distribution using aseptic techniques.
  2. Perform routine batch manufacturing of radioisotopes following standard operating procedures (SOPs) in accordance with the master batch record (MBR).
  3. Provide required documentation for batch records.
  4. Develop and apply SOPs for radiopharmaceutical manufacturing and safety processes.
  5. Develop novel radiochemical manufacturing processes. Implement existing radiochemical manufacturing methods through cGMP Technical Transfer activities and radiation safety practices.
  6. Provide support for procurement and lifecycle management of consumable and raw materials used for radioisotope and radiopharmaceutical manufacturing.
  7. Comply with the radioactive waste disposal program under the Nuclear Regulatory Commission (NRC).
  8. Support the inventory of all laboratory chemicals under regulatory and safety protocols.
  9. Provide training and development to employees regarding chemical, hazardous, and radioactive material safety.
  10. Collaborate with the scientific, engineering, and quality teams to conduct research to support ongoing product development and process improvements to meet drug manufacturing, quality and regulatory compliance goals.
  11. Ensure operations are conducted in accordance with regulations of the Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT), and other applicable agencies.
  12. Serve as a content expert in the development and execution of new products and services.

Qualifications:

  • Bachelor, master, or doctorate degree in radiochemistry, nuclear engineering, chemical engineering, engineering, radiation biology, health physics, physics or related field of study
  • Prior experience in radiopharmaceutical or related industry experience
  • Knowledge of aseptic techniques for pharmaceutical preparations
  • Ability to analyze and interpret technical procedures and governmental regulations
  • Strong ability to understand complex radiochemistry processes, and review scientific journals, third party manufacturing documents, and regulatory guidance from regulatory agencies including, but not limited to: Nuclear Regulatory Commission (NRC), US-Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), US Pharmacopoeia (USP), International Council of Harmonization (ICH), US Department of Transportation (DOT), US Department of Energy (DOE), in order to develop and improve new radiochemistry methods
  • Functionally skilled to troubleshoot, solve abstract issues, develop and implement quality assurance and regulatory affairs policies and procedures
  • Experience in radiopharmaceutical development and manufacturing, preferred
  • Knowledge of Actinium-225 and Astatine-211, preferred
  • Glovebox and hot cell environment experience, preferred

To apply, email your resume to hr@ionetix.com

Ionetix is an Equal Opportunity Employer.