This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11611383 Department

　　BSD RAD - Cyclotron

　　About the Department

　　The Cyclotron Facility at the University of Chicago is the only academicCyclotron Facility in the state of Illinois and has been operationalsince 2017. The Facility manufactures radioactive pharmaceuticals forhuman (and animal) use. The Facility holds its own FDA approvedInvestigational New Drug (IND) application for one human use,clinical-trial radiopharmaceutical and is listed as the manufacturer onthe INDs of three other INDs that are held by other Institutions and arealso for clinical trials involving humans.

　　While we produce IND drugs for humans, plans are being executed toproduce clinical drugs for use here at the Hospital of the University ofChicago. Regulatory compliance for clinical drugs is similar, but morestringent, than the requirements for IND drugs. Therefore, experiencedpersonnel are critical to operations and regulatory compliance.

　　Our staffing requirements are highly unusually. For this position, theapplicant needs to have skills in 1) chemistry, pharmacy, orbiochemistry/molecular chemistry, 2) microbiology/chemistry experience,3) experience with regulatory affairs, procedural reviews, and audits,4) experience in working in high levels of radiation and with largeamounts of radioactivity is very desirable, but not required, and 5) andclear ability to work in a complex, sometimes high-stress, andmultiple-worker environment for example a pharmaceutical productionfacility, a pharmacy, or a Cyclotron Facility would all be appropriate.

　　Job Summary

　　This position is for a manager level quality assurance professional whoalso has scientific skills. The candidate should have experience in drugmanufacturing, radiopharmaceutical production, and/orchemistry/biochemistry/microbiological experience. The candidate willdevelop and maintain a robust Quality Assurance Program for our drugproduction but will also be expected to participate in direct QualityControl testing of our drugs. The candidate will also oversee allscheduling activities and purchasing of supplies, reagents, andchemicals in collaboration with the Director and Associate Director ofthe Facility. The candidate must be experienced in analytical testingand have demonstrated science experience in an appropriate fieldapplicable to our drug productions. The candidate will be responsiblefor developing a robust training program in consultation with theFacility Director that covers all aspects of operations. The candidatewill be trained in: radiation safety, to operate our particleaccelerator used in our radiopharmaceutical production and in the drugproduction processes also. Excellent organizational and communicationsskills and meticulous following of Standard Operating Procedures arerequired.

　　Responsibilities

　　Manages the Cyclotron Facility with emphasis on Operations and QualityAssurance.

　　Oversees and manages scheduling of production, interfacing withrequesters, all purchasing, day-to-day operations.

　　Oversees and manages quality assurance including daily quality controltesting of finished drug, facility maintenance and compliance, training,documentation and inventory control.

　　Participates in direct microbiological, biochemical, and analyticaltesting of final drug products.

　　Must be willing and comfortable handling large amounts of radioactivematerials and working in radiation environments.

　　Manages scheduling of production for internally/externally used finaldrug products. Includes invoicing, maintaining production calendars,interfacing with receiving institutions, and appropriate billing ofreceiving parties.

　　Inventory control, purchasing and other administrative tasks needed torun the facility.

　　Participates in the q ality control testing of producedradiopharmaceuticals on a daily basis as needed.

　　Develops, implements, and oversees training programs for synthesis,QA/QC work, operations, and general procedures based on existing and tobe written SOPs.

　　Participates, implements, and monitors regulatory compliance throughoutthe entire Cyclotron Facility Structure. This includes regulatoryfilings like INDs and ANDAs with the FDA. Proven knowledge of regulatorypractices as evidenced by prior work experience in any setting that ishighly regulated and controlled.

　　General management of staff with the Director/Associate Director

　　Writes, proofs, and develops standard operating procedures (SOPs) asnecessary.

　　Performs internal monthly audits of various functional areas of thefacility.

　　Participates with general lab maintenance, including sanitation.

　　Familiar with how the Cyclotron Accelerator works. Basic understandingof the accelerator and its subsystems in order to oversee maintenanceand production schedules, running the machine on an intermittent basis.

　　Provides expertise to researchers on compliance of research activitieswith institutional, state, and federal regulatory policies, procedures,directives and mandates.

　　Provides expertise to researche