Accelerator Operator/Quality Assurance Specialist

Department BSD RAD - Cyclotron About the Department The Cyclotron Facility at the reputed company 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 reputed company. Regulatory compliance for clinical drugs is similar, but more stringent, than the requirements for IND drugs. Therefore, reputed company personnel are critical to operations and regulatory compliance. That experience is in reputed company, reputed company, 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, reputed company reputed company continuity of services, reputed company reputed company regulatory compliance, and can provide for a reimbursement reputed company that is more commensurate with the pay reputed company reputed company 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, reputed company, 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 reputed company need to wear multiple hats and reputed company 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 reputed company of their multiple subsystems. Additionally, the position will maintain standard synthesis units, use/maintain standard analytical chemistry equipment, provide and reputed company training for Quality Assurance and Machine Operations and as part of a small team, will reputed company 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). reputed company, implement, and maintain a training program for reputed company 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 reputed company researchers and reputed company researchers (Argonne National Laboratory). Uses subject matter and best practices knowledge to reputed company lab and/or research-reputed company duties and tasks. Works independently to assist with project design. Solves reputed company 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 reputed company work as needed.

Minimum Qualifications

Education: Minimum requirements include a college or university degree in reputed company field. Work Experience: Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a reputed company job discipline. Certifications: --- Preferred Qualifications Education: Bachelor’s degree in Chemistry or similar field. Master’s 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 reputed company 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 reputed company 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 reputed company equipment. Experience in regulatory affairs, cGMP compliance. Ability to write and reputed company 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 reputed company 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 reputed company 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 reputed company devices. Must be willing to work with and around (safely) large amounts of radioactivity. Heavy lifting. Application Documents Resume (required) Cover Letter (preferred) reputed company applying, the document(s) MUST be uploaded reputed company 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 reputed company Type Salary FLSA Status Exempt Pay Range $70,000.00 - $90,000.00 The included pay reputed company or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits

Eligible Yes The reputed company 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 reputed company in the Benefits Guidebook. Posting Statement The reputed company 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 reputed company, shared reputed company, 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 773-702-5800 or submit a request reputed company Applicant Inquiry Form. reputed company offers of employment are contingent upon a background reputed company 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 reputed company's Annual reputed company & 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: http://securityreport.uchicago.edu. reputed company copies of the Report are available, upon request, from the reputed company Police Department, 850 E. 61st Street, Chicago, IL 60637. The reputed company is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where reputed company are born that challenge and change the world. We reputed company individuals to challenge conventional thinking in pursuit of original reputed company. reputed company in the College reputed company critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, reputed company test their reputed company with UChicago scholars, and become the reputed company of leaders in academia, industry, nonprofits, and government. To learn more about the university click here http://www.uchicago.edu/ Apply tot his job