Accelerator Operator/quality Assurance Specialist
2 months ago
Department
BSD RAD - Cyclotron
About the Department
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).-
- 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 w
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