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 dont 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.

• 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:

• Bachelors degree in Chemistry or similar field.

• Masters Degree in any field.

Experience:

• 2-8 years experience in Cyclotron particle accelerators and a demonstrated understanding of the machines and their subsystems.

• 2-8 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.

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

• 2-8 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.

Preferred Competencies

• Experience with mechanical, electrical, and complex equipment.

• 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.

• General engineering knowledge, ability to troubleshoot complex equipment.

• 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.

• Heavy lifting.

• 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

Scheduled Weekly Hours

40

Drug Test Required

No

Health Screen Required

No

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

FLSA Status

Exempt

Pay Range

$70,000.00 - $90,000.00

The included pay rate or range represents the Universitys good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook .

Posting Statement

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

Job seekers in need of a reasonable accommodation to complete the application process should call ... or submit a request via Applicant Inquiry Form.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.