Accelerator Operator/Quality Assurance Specialist - JR30347-3800

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**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 two

other, soon to be three other INDs 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. As an example, for our last hire, we only received 4

applicants even though the position was posted for multiple weeks. Two

of the four applicants were completely inappropriate - not having the

correct backgrounds or skill sets.

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 4 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 Quality Assurance and 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**

- Formulate, implement, and monitor regulatory compliance throughout

the entire Cyclotron Facility Structure.

- Run and maintain the Cyclotron Accelerator. Participate, initiate,

and diagnose cyclotron quipment, including sub-systems.

- Writing, proofing, and developing Standard Operating Procedures

(SOPs).

- Develop, implement, and maintain a training program for all members

of the Facility.

- Participate in 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.

- Liaison between Cyclotron Facility and University of Chicago

researchers and outside researchers (Argonne National Laboratory).

- Uses subject matter and best practices knowledge to perform lab

and/or research-related duties and tasks. Works independently to

assist with project design.

- Solves complex problems relating to the administration of projects,

including planning new procedures, adapting existing procedures to

the needs of the project, and making significant contributions to

methodology.

- Performs other related work as needed.

**Minimum Qualifications**

**Education:**

Minimum requirements include a college