Biological Sciences Division at the University of Chicago · 1 day ago
Temporary cGMP Operations Intern
Chicago, IL
Internship
Onsite
Intern
$18/hr - $22/hr
1+ years expThe University of Chicago's Biological Sciences Division is seeking a Temporary cGMP Operations Intern to assist in facility operations within the cGMP Core. This internship provides an opportunity to learn about clinical research, cGMP facility operations, and cell & gene therapies while maintaining compliance with regulatory standards.
Higher Education
Responsibilities
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
Perform all other duties as requested by the Technical Director or QA/QC Manager
Performs other related work as needed
Qualification
Required
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
High School Diploma required
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
Resume
Cover Letter
Three Science/Supervisor Reference Contact Information
Preferred
Experience with Microsoft Office Suite preferred
A minimum of 1-2 year of science laboratory courses
Significant progress towards their degree in a science discipline preferred
Company
Biological Sciences Division at the University of Chicago
As part of the University of Chicago, the Biological Sciences Division (BSD) pursues globally impactful solutions to seemingly unsolvable challenges.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase