This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12435254 Department

BSD SRF - cGMP

About the Department

The primary mission of the Cellular and Tissue Based Processing cGMP Facility is to manufacture cell-based products and clinical grade reagents for treatment of patients on Phase I, II and III clinical trials. This subcore was developed in 2001 to accommodate the growing number of clinical trials that require highly manipulated cellular products for patient treatment. The cGMP facility is registered with the FDA in accordance with 21 CFR part 1271. This registration complies with federal regulations that require clinical facilities engaged in production of cellular products follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose. The facility is capable of providing a range of services dedicated for supporting cellular based therapies including vaccines for patient treatments.

Job Information

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:

• 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.

Additional Responsibilities

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.