Hyde Park Campus
20114 BSD Shared Research Facilities
About the Unit
The Office of Shared Research Facilities (OSRF) oversees the core facilities, which make up a pivotal and essential part of the research ecosystem, providing critical resources that enable existing and emerging technologies to facilitate groundbreaking discoveries. OSRF Cores offer expertise in state-of-the-art instrumentation and services as well as experimental design and data analysis to advance research programs across the disciplines. Operated as fee-for-service facilities, OSRF cores are managed in order to best support the University's mission to discover and create new knowledge of living systems. We are driven by the research needs of the faculty. The University of Chicago cGMP Core which is part of the Biological Sciences Division (BSD) offers a state of the art controlled laboratory environment as well as resources and consultative services for preparing cellular and biological products for human clinical trials. The Facility is FDA registered and follows regulations set forth by 21CFR Part 1271, which outlines requirements for preparing human cells, tissues and tissue-based products for treating patients.
Under the supervision of the Technical Director of the cGMP Core this position requires the candidate to collaborate within a team atmosphere that manufactures clinical grade vaccine products in the cGMP cleanroom facility. The candidate reports to the QC/QA Manager. This candidate will also work independently and be assigned back up duties to support the maintenance of the facility operations.
- Takes particle counts in the Cleanroom Production Areas, takes environmental monitoring (EM) samples in production areas (with Rodac Plates) and prepares reports
- Processes supply orders on Buysite and through pharmacy, processes inventory – obtains certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items
- Stocks Facility and supporting areas with supplies and gowns
- Maintains inventory levels for facility, vaccine preparations, cell therapy and islet preparations
- Performs Endotoxin assays as need for Cell Therapy Process
- Schedules and prepares microbiology lab forms in 4Medica for EM samples
- Delivers sterility and gram stain samples to Microbiology and obtains results through 4Medica and/or directly with Microbiology Lab personnel
- Prepares kits of supplies used in manufacturing for all campaigns
- Performs room change-over in facility after campaigns with specialized cleaning to maintain GMP environment per regulations
- Processes gowns to Aramark for sterilizing/cleaning and maintains inventory levels
- Assists with facility repairs/maintenance by interacting with vendors, repair and physical plant personnel
- Transports prepared vaccines/cell therapy products to the clinic or pharmacy, test and check eye wash station, change gas tanks and maintain chemical inventory for EH&S
- Ability to demonstrate excellent interpersonal and communication skills required
- Ability to gown and work in an aseptic/cleanroom environment
- Strong emphasis on documentation according to FDA regulations
- Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs
- Excellent verbal and written communication skills
- Capacity to exhibit organizational skills required
- Ability to work in a collaborative team environment
Education, Experience, or Certifications:
- Bachelor's degree in a scientific field required
- 1 year or more experience working in a laboratory environment preferred
- Experience with laboratory skills and techniques
- Advanced skills with Microsoft Office Suite
Technical Knowledge or Skills:
- Capacity to handle multiple tasks and competing demands under tight timeframes
- Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment
- Ability to understand and carry out instructions and solve problems in complex situations
- Ability to read and write documents including protocol and SOP's
- Ability to independently learn new techniques
- Ability to interact with all levels of staff in a professional manner while respecting confidentiality
- Excellent customer/staff interpersonal skills
- Cover Letter
- Reference Contact Information
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Remove from Posting On or Before
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