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　　BSD SRF - cGMP

　　About the Department

　　The primary mission of the Cellular and Tissue Based Processing cGMPFacility is to manufacture cell-based products and clinical gradereagents for treatment of patients on Phase I, II and III clinicaltrials. This subcore was developed in 2001 to accommodate the growingnumber of clinical trials that require highly manipulated cellularproducts for patient treatment. The cGMP facility is registered with theFDA in accordance with 21 CFR part 1271. This registration complies withfederal regulations that require clinical facilities engaged inproduction of cellular products follow strict guidelines to minimizemicrobial contamination and manufacture cellular-based products that aresterile and potent for their intended purpose. The facility is capableof providing a range of services dedicated for supporting cellular basedtherapies including vaccines for patient treatments.

　　Job Summary

　　The job performs routine assignments related to the documentation,analysis, and reporting of research data. Provides input to support thestrategic, administrative, operational, and financial decisions thatimpact clinical research conducted across the University.

　　Under the supervision of the Technical Director and facility manager ofthe cGMP Core, this position requires the candidate to collaboratewithin a team atmosphere that process and compound clinical gradevaccines and cell therapy products in the Cellular and Tissue BasedProcessing cGMP Facility. This position requires the candidate to adhereto sponsored clinical trial protocols and standard operating proceduresas well as working off hours at times. The ideal candidate will need tobe a self-starter and be responsible for maintaining strict complianceunder various regulatory agencies and detailed record keeping. Thiscandidate will be required to juggle multiple/competing priorities andalso be assigned back up duties to support facility operations. Thecandidate must be open to undergoing and pass rigorous training withrespect to cGMP and USP standards as well as various technical assaysand procedures specific for various cellular manipulation techniques.

　　Responsibilities

　　Quality Control and Validation.

　　Perform environmental monitoring in the Production Areas including butnot limited to: dynamic monitoring for campaigns, biweekly particlecounts and monthly air samples and prepare reports.

　　Perform personnel monitoring for required campaigns.

　　Assist in the set up new lab equipment used in Quality ControlLaboratory and assist with upkeep such as setup, temperature monitoring,daily verification with QC, instrument/operation/performancequalifications (IQ/OQ/PQ), routine maintenance, troubleshooting.

　　Support cGMP compliance through validation and qualification ofprocesses, material and supplies, equipment and facility processes,perform vendor qualification of manufacturing supplies and material.

　　Ensure all equipment are operating correctly.

　　Ensure all materials and samples are stored correctly at the righttemperatures.

　　Facility Operations.

　　Help monitor and maintain compliance with institutional, state, andfederal regulatory policies and procedures and accreditingorganizations.

　　Process supply orders on Buysite and through pharmacy, processesinventory-obtain quality certificates (Certificate of Analysis,Certificate of Sterility, Certificate of Conformance, etc.) for allitems.

　　Prepare kits of supplies used in manufacturing for all campaigns.

　　Maintain inventory levels for facility operations, vaccine preparations,cell therapy, and islet preparations.

　　Assist in facility expansion projects with the Technical Director andQA/QC Manager.

　　Assist in instrumentation rror reports and deviations.

　　Perform room change-over in facility after campaigns with specializedcleaning to maintain GMP fashion.

　　Assist with facility repairs/maintenance with University of ChicagoPlant personnel and vendors.

　　Attend all required training and comply with all safety and operationsprocedures.

　　Perform all other duties as requested by the Technical Director or QA/QCManager.

　　Cellular Processing and Manufacturing.

　　Provide backup support to variety of cellular product processingprocedures under G\'X\'P (GLP, GTP, GMP, GDP) guidelines as directedwith speed and accuracy.

　　Provide backup support to variety of cellular infusion procedures underGTP guidelines as directed with speed and accuracy.

　　Transport prepared vaccines/cell therapy products to the clinic orpharmacy.

　　Coordinates and may participate in quality assurance reviews conductedby study sponsors, federal agencies, or specially designated reviewgroups.

　　Analyzes study-related documentation, such as protocol worksheets,procedural manuals, adverse event reports, institutional review boarddocuments, or progress repo