1) Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
2) Support cGMP facility operations including validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.
3) Perform a variety of procedures for cellular product processing under Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.
4) Transport prepared vaccines/cell therapy products to the clinic or pharmacy
5) Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP fashion
6) Perform various assays including but not limited to proficiency and competency assays as need for Cell Therapy processes
7) Develop, write, and maintain various assays as need for Cell Therapy processes to standard best practices
8) Develop, write, and maintain various standard operating procedures as needed for facility operations
9) Set up new lab equipment used in Quality Control Laboratory and assist with upkeep such as setup, temperature monitoring, daily verification with QC, instrument/operation/performance qualifications, routine maintenance, troubleshooting
10) Ensure all materials and samples are stored correctly at the right temperatures
11) Write instrumentation error reports and deviations
12) Provide backup support to the cGMP Cell Therapy Technician as needed/directed
13) Perform environmental monitoring in the Production Areas including but not limited to biweekly particle counts and monthly air samples and prepare reports as directed
14) Deliver samples to Clinical Microbiology and obtain results through 4Medica and/or directly with Micro Lab personnel
15) Attend all required training and comply with all safety and operations procedures
16) Perform all other duties as requested by the Technical Director or QA/QC Manager
Unit -specific Competencies
1) Working knowledge of Gâ™Xâ™P 2) Must be detail-oriented, well organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment 3) Must be able to manage multiple and rapidly changing priorities and have the ability to quickly learn new skills
4) Ability to demonstrate excellent interpersonal and communication skills 5) Strong emphasis on documentation according to FDA regulations and other regulating bodies 6) Execute and lead operation to comply with all oral and written procedures including Batch Records and SOPs 7) Excellent verbal and written communication skills 8) Capacity to exhibit organizational skills 9) Ability to work in a collaborative team environment 10) Capacity to handle multiple tasks and competing demands under tight timeframes 11) Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment 12) Ability to understand and carry out instructions and solve problems in complex situations 13) Ability to read and write and follow documents including protocol and SOPs 14) Ability to independently learn new techniques 15) Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality 16) Excellent customer/staff interpersonal skills
1) Ability to perform light/medium work, which includes lifting up to 30 pounds
2) Occasionally must bend, twist, squat, climb, reach, stoop, and kneel
3) Ability to be mobile walking from building to building
4) Ability to sit for some period of up to 2 hours
5) All employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste
1) Bachelor's degree in Science in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely related fieldÂ
2) Advanced degree
1) Four years of laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field. A related masterâ™s degree may offset years of experience at 1:1 (i.e., a two-year masterâ™s degree in lieu of two years of experience).Â 2) Advanced skills with Microsoft Office Suite
2) Cover Letter
3) Three Science/Supervisor Reference Contact Information
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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Internal Number: JR07195
About University of Chicago (UC)
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