Job Description:

Job Summary:

Under the supervision of the Technical Director and facility manager of the cGMP Core, the Temporary cGMP Operations Intern will assist cGMP staff in facility operations of the core. This internship is a great opportunity to introduce the individuals to clinical research, cGMP facility operations and maintenance, and cell & gene therapies at the University of Chicago.  

The ideal candidate should be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping.

Responsibilities:

• â‹Perform environmental monitoring in the Production Areas including biweekly particle counts and monthly air samples and prepare reports.

• Assist in the set-up of lab equipment and new cleanrooms used in the cGMP core and assist with upkeep such as setup, temperature monitoring, daily verification with QC, routine maintenance, troubleshooting.

• Assist in cGMP compliance through validation and qualification of processes, maintaining inventory of materials and supplies, equipment, and facility processes.

• Process supply orders and obtain quality certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.).

• Prepare kits of supplies used in manufacturing for all campaigns.

• Perform cleanroom change-over in facility after campaigns with specialized cleaning to maintain cGMP fashion.

• Attend all required trainings and comply with all safety and operations procedures.

• Learn basic laboratory techniques for cell therapy such as manual cell counting, automated cell counting, endotoxin testing, cell freezing.

• Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Performs other related work as needed.

• Perform all other duties as requested by the Technical Director or QA/QC Manager.

Competencies:

• Ability to work in a cGMP sterile clean room setting is required.

• Ability to read and write and follow documents including protocol and SOPs.

• Capacity to handle multiple tasks and competing demands under tight timeframes.

• Execute and comply with all oral and written procedures in the SOPs.

• Attention to detail.

• Ability to demonstrate excellent interpersonal and communication skills; required.

• Excellent verbal and written communication skills.

• Capacity to exhibit organizational skills; required.

• Ability to work in a collaborative team environment.

• Ability to understand, retain, and carry out instructions and solve problems in complex situations.

• Ability to interact with all levels of staff in a professional manner while respecting patient confidentiality.

• 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.

Education, Experience, or Certifications:

Education:

• High School Diploma required.

• Pursuing a degree (Bachelors or Masters) in science, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field is required.

• Significant progress towards their degree in a science discipline preferred.

Experience:

• Experience with Microsoft Office Suite required.

• 1-2 year of science laboratory courses is required.

Working Conditions and Physical Requirements:

• Ability to perform light/medium work, which includes lifting up to 30 pounds.

• Occasionally must bend, twist, squat, climb, reach, stoop, and kneel.

• Ability to be mobile, walking from building to building.

• Ability to sit for some period of up to 2 hours.

• All employees within this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste.

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Required Documents:

• Resume

• Cover Letter

• Three Science/Supervisor Reference Contact Information

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.

The University of Chicago's Annual Security & 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: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

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