Technical Expertise Provide technical expertise in bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices. Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers. Develop responses to microbiology and sterilization related requests and audit finding

Take a leadership role in production team deliverables and projects Work with other employees on the Production and Quality teams. Work with Quality Unit to ensure readiness for inspections. Maintain compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies. Working as an active member of the production team on the floor, when needed. Review and approval of pro

Perform radioactive isotope elution and chelation as part of GMP manufacturing according to written procedures. Maintain batch records, equipment logs, and other production records as directed per company procedures. Work concurrently with Quality Assurance personnel to deliver a quality product. Follow and adhere to production schedules and timelines. Execute room and eq

Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state of the art facility for commercial scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. Job Re

Orano Med Orano Med has developed new processes for producing high purity lead 212, a rare radioactive isotope. Lead 212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on near

Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed. Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records. Collect data for process qualification and implementation. Owning or supporting investigations relat

OranoMed is seeking a Production Operator for the production team at ATLab Indianapolis ("ATLab IND"), a new facility for commercial scale manufacturing of sterile therapeutic radiopharmaceuticals. The top priority for the Production Operator will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards f

The Safety Officer manages the Radiation Safety, Chemical Safety, and Environmental Health & Safety programs and serves as the subject matter expert for safety regulations impacting the various departments. Duties include developing policies and procedures in accordance with applicable regulatory entities. Primary Job Duties Radiation Safety Officer Formulates, prepares,