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 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.

Job Summary

The job manages scientific research projects or scientific research facilities. Uses considerable on-the-job experience to ensure compliance of research activities with institutional, state, and federal regulatory policies.

Works independently to write articles, reports and manuscripts, and presents research findings at meetings and / or conferences.

The role will work with the facility which produces 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, and experienced personnel are critical to operations and regulatory compliance.

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 role requires and will involve regulatory affairs knowledge and experience combined with the ability to operate, repair, diagnose, and maintain a modern particle accelerator.

Responsibilities

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.

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.

Help to maintain standard synthesis units, use and maintain standard analytical chemistry equipment.

Help as part of a small team to develop new drugs based on investigators requirements.

Provide and lead the training program for Quality Assurance, Machine Operations and monitor / track training in all other procedures.

Formulate, implement, and monitor regulatory compliance throughout the entire Cyclotron Facility Structure.

Run and maintain the Cyclotron Accelerator. Participate, initiate, and diagnose cyclotron equipment, 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 or university degree in related field.

Work Experience :

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Certifications :

Preferred Qualifications

Education :

Bachelor’s degree in Chemistry.

Master’s Degree in any field strongly preferred.

Work experience in lieu of educational credentials will be considered.

Experience :

5-7 years’ experience in Cyclotron particle accelerators and a demonstrated understanding of the machines and their subsystems.

5-7 years’ experience in Good Manufacturing Practices.Proven knowledge of GMP and regulatory compliance covering all areas : aseptic procedures, general QC procedures, facility maintenance, documentation, etc.

5-7 years’ radiopharmaceutical experience in the radiolabeling and Quality Control of compounds.Must be able to demonstrate understanding and experience with standard analytical equipment : HPLC, TLC, GC, aseptic procedures.

Must be willing to work with large amounts of radioactivity.

5 or more years lab work in radiochemistry or related fields / areas.Experience with the LabLogic software packages.Experience with 18F, synthesis platforms, especially the IBA Synthera platform.

Experience with multiple accelerator systems (Siemens, GE, ABT, etc.).

Preferred Competencies

Experience in regulatory affairs, cGMP compliance.

Ability to write and develop Standard Operating Procedures.

Experience in running a cyclotron and maintenance.

Must be able to work flexible (early morning) hours.

General chemistry knowledge background with emphasis on radiolabeling chemistry.

Must be capable of working alone and working collaboratively in a small group with demonstrated problem solving capabilities under pressure situation.

Must be able to work in a non-standard working environment with multiple duties that can change daily.

Must be willing to work with and be exposed to radioactivity (but maintaining University Safety standards).

Must be willing to work with chemicals and equipment in a complex environment.

Must have excellent organization, cleanliness, and work habits.

Must be able to follow procedures exactly.

Leadership, initiatives.

Proven record of radiolabeling using multiple PET radioisotopes.

Demonstrated publications record.

Experience with nucleophilic reactions.

Machine shop skills / experience

Experience with radiosynthesis platforms : Neptix, GE units, Trasis, IBA Synthera, Syntha, Eckert & Ziegler, etc.

Understanding of clinical nuclear medicine operations and experience with Just-In-Time production of radiopharmaceuticals.

DOT training in the shipping of dangerous goods.

Experience in working with Plant / Maintenance personnel.

Experience in working with Construction Personnel (for Facilities renovations).

Experience working in ISO-7 through ISO-5 environments.

Working Conditions

Laboratory environment.

Construction environment.

Requires extensive safety training.

Irregular work schedule.

High noise environment.

Exposure to chemical agents.

Requires protective devices.

Must be willing to work with and around (safely) large amounts of radioactivity.

Heavy lifting.

Application Documents

Resume (required)

Cover Letter (preferred)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

Benefits Eligible

Drug Test Required

Health Screen Required

Motor Vehicle Record Inquiry Required

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