Accelerator Operator/Quality Assurance Specialist

Department

BSD RAD - Cyclotron

About the Department

The Cyclotron Facility at the University of Chicago is the only academic Cyclotron Facility in the state of Illinois and has been operational since 2017. The Facility manufactures radioactive pharmaceuticals for human (and animal) use. The Facility holds its own FDA approved Investigational New Drug (IND) application for one human use, clinical-trial radiopharmaceutical and is listed on the INDs of three others that are held by other Institutions (two private corporations and Washington University of St. Louis) and are also for clinical trial involving humans.
While we produce IND drugs for humans, plans are being executed to produce clinical drugs for use here at the Hospital of the University of Chicago. Regulatory compliance for clinical drugs is similar, but more stringent, than the requirements for IND drugs. Therefore, experienced personnel are critical to operations and regulatory compliance. That experience is in very, very, short supply. Our academically based Facility must compete with the numerous commercial operators of cyclotrons in the greater Chicago area who are able to provide higher pay levels.

This means that retention of existing personnel is crucial to our operations. By retaining staff, we avoid having to re-train workers in our procedures, we don’t disturb established responsibilities of our staff, achieve better continuity of services, achieve better regulatory compliance, and can provide for a reimbursement rate that is more commensurate with the pay rate outside of academia.
Programmatically, and in conjunction with the hospital, Radiology and the Cyclotron Facility are moving towards the production of at least two, new to the Cyclotron, clinical drugs, 13N-ammonia and 68Ga-PSMA for cardiac and prostate cancer respectively. This increases our workload substantially and is another reason that the retention of critical, experienced, and trained personnel is needed for the development and growth of the facility.

With respect to this position, the combination of regulatory affairs knowledge and experience combined with the ability to operate, repair, diagnose, and maintain a modern particle accelerator narrows the field of possible applicants even further. In a typical, commercial, or larger academic Facility, typically these positions would be split among different staff members. But our Facility is only staffed by 5 FTEs and therefore we all need to wear multiple hats and perform multiple functions. Again, this limits the possible applicant pool.

Job Summary

Overall responsibility for Machine Operations (and repair) and Quality Assurance/Regulatory Compliance of the Facility, including Quality Control testing of the radioactive pharmaceuticals that are produced by the Cyclotron Facility. This role will help to maintain the Cyclotron and to operate the accelerator, requires highly specific knowledge of particle accelerators, their operation/function, and all of their multiple subsystems. Additionally, the position will maintain standard synthesis units, use/maintain standard analytical chemistry equipment, provide and lead training for Quality Assurance and Machine Operations and as part of a small team, will develop new drugs based on investigators requirements.

Responsibilities

• Run and maintain the Cyclotron Accelerator and provide engineering support.  Must be familiar with the basics of particle accelerators and their subsystems either formally (education) or operationally (experience).  Participate, initiate, and diagnose cyclotron equipment, including sub-systems.        

• Formulate, implement, and monitor regulatory compliance throughout the entire Cyclotron Facility Structure.  Proven knowledge of the basics of Good Manufacturing Practices as evidenced by prior work experience in Radiopharmaceutical Production or Drug Manufacturing or Clinical Setting.

• Writing, proofing, and developing Standard Operating Procedures (SOPs).                                 

• Develop, implement, and maintain a training program for all members of the Facility.              

• Participate in engineering support and maintenance of analytical/synthesis equipment evidenced by experience working with these units.

• Participate with general lab maintenance, including sanitation, inventory control, ordering and other administrative tasks needed to run the facility.                                                                                       

• Knowledge and work with aseptic procedures, microbiological procedures (including disposal of materials), handling of highly radioactive pharmaceutical products, DOT procedures.