Research Specialist 3
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 Core facility. This candidate will also work independently and be assigned back up duties to support the maintenance of the facility operations.
- Review and analyze facility particle counts, viables and cleaning, gowning, inventory and sterilization/cleaning documents for adherence to Standard Operating Procedures and cGMP Regulations
- Prepare reports for particle counts, viables, cleaning, gowning, inventory, prepare labels and other documents
- Write SOPs, Deviations, Instrument Error Reports, Product Master Lists and other facility documents
- Interact with suppliers, vendors, plant personnel to order supplies, investigate new products for the facility, coordinate repairs in facility, investigate alarms, help with vendor repairs and calibration of equipment
- Clean facility, take particle counts, process inventory, perform EM sampling, process gowns and other cleanroom technician duties as back up cleanroom technician
- Coordinate work flow and meetings with the islet transplant group
- Train islet team on all aspects of cGMP facility use
- Oversee the work performed by the cleanroom technician
- Review and assist in preparation of Standard Operating Procedures for the submission of the Biological License Application (BLA) to the FDA for islet isolation and transplantation under the supervision of the cGMP Facility technical director.
- 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
- Knowledge of basic math computation skills
Education, Experience and Certifications:
- Bachelor's degree required; in a scientific field preferred
- Experience working in a cGMP Cleanroom environment required
- Experience with laboratory skills and techniques
- Science background and Quality Control/Assurance experience preferred
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 problem solve scientific and technologically
- 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 Qualification
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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