At IONETIX, we are revolutionizing the production of medical isotopes and radiopharmaceuticals through innovative cyclotron technology and end-to-end manufacturing solutions. Our mission is to improve patient access to life-changing therapies by developing and producing high-quality radioisotopes and radiopharmaceutical products.
We are seeking a Production Chemist to join our growing team in Lansing, Michigan. This position offers an exciting opportunity to contribute directly to the production of radioisotopes and investigational and commercially approved radiopharmaceuticals in a highly regulated, cutting-edge environment.
Position Summary
This role applies foundational scientific principles in radiochemistry and pharmaceutical manufacturing to execute production processes, ensure regulatory compliance, and maintain product quality.
This position exercises independent technical judgment in the execution of batch production, documentation review, and troubleshooting within established procedures. All operations are conducted in compliance with regulations and guidance from the Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT), and other applicable federal, state, and local regulatory agencies.
In this role, you will have the opportunity to:
- Perform routine batch manufacturing of radioisotopes and radiopharmaceutical products in accordance with approved Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and current Good Manufacturing Practices (cGMP).
- Prepare quality control (QC) samples and dispense radioisotope products for customer distribution using validated aseptic techniques and radiation safety practices.
- Accurately complete, review, and verify batch production documentation to ensure data integrity and regulatory compliance.
- Maintain contamination control through proper gowning, aseptic technique, cleaning, and decontamination procedures.
- Apply scientific knowledge to identify, troubleshoot, and resolve routine production deviations in collaboration with senior technical staff.
- Assist with implementation, qualification, and validation of new or revised radiochemical manufacturing methods while ensuring compliance with cGMP and radiation safety standards.
- Contribute to the drafting, review, and revision of SOPs related to radiochemical production and laboratory safety.
- Participate in quality investigations, deviation documentation, and corrective and preventive action (CAPA) activities.
- Support procurement, qualification, and lifecycle management of consumables and raw materials used in manufacturing operations.
- Maintain laboratory chemical inventories in accordance with regulatory, safety, and internal control requirements.
- Comply with radioactive waste handling and disposal programs under NRC regulations.
- Provide technical input during internal audits and regulatory inspections.
Ideal candidates will possess:
- Associate or Bachelor’s degree in radiochemistry, chemistry, chemical engineering, nuclear engineering, physics, or related field of study
- Minimum one (1) year of GMP manufacturing, laboratory production, or related industry experience
- Must obtain and maintain required licensing, certifications, and radiation safety training, necessary to perform essential job functions
- Experience in manufacture/production and handling of radioactive materials/radioisotopes, preferred
- Experience with cyclotron-produced radioisotopes, preferred
- Experience working with glovebox and hot cell environment, preferred
- Experience working in glovebox and hot cell environments.
- Experience working in regulated pharmaceutical, radiopharmaceutical, or biotechnology environments.
- High level of integrity, professionalism, accountability, and dependability.
- Ability to work safely with sources of ionizing radiation and follow radiation safety principles.
- Ability to work flexible hours to support production schedules and business needs.
Why Ionetix?
At Ionetix, we are pioneers in advancing radiopharmaceutical production, delivering innovative solutions that make a difference in healthcare. Joining our team means being part of an organization that values excellence, collaboration, and professionalism.
What We Offer:
This position receives a competitive wage, commensurate with experience, and an excellent benefits package, including medical, dental, vision, life insurance, 401(k) and match, stock options, and generous paid time off.
If you are passionate about science, manufacturing excellence, and advancing the future of nuclear medicine, we encourage you to apply.
Submit your resume to [email protected].
IONETIX is an Equal Opportunity Employer.
