cGMP Cell Therapy Technician

Job Description:

Unit specific Responsibilities

1) Helps monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.

2) Support cGMP facility operations including validation and qualification of processes, material and supplies, equipment and facility processes, perform vendor qualification of manufacturing supplies and material.

3) Process supply orders on Buysite and through pharmacy, processes inventory â“ obtain quality certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items

4) Stock facility and supporting areas with supplies and personal protective equipment

5) Prepare kits of supplies used in manufacturing for all campaigns

6) Maintain inventory levels for facility operations, vaccine preparations, cell therapy, and islet preparations

7) Process gowns and scrubs to send to vendor for sterilizing/cleaning and maintain inventory levels

8) Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP fashion

9) Perform various assays including but not limited to proficiency and competency assays as need for Cell Therapy processes

10) Schedule and prepare microbiology lab forms in 4Medica

11) Perform environmental monitoring in the Production Areas including but not limited to biweekly particle counts and monthly air samples and prepare reports.

12) Deliver samples to Clinical Microbiology and obtain results through 4Medica and/or directly with Micro Lab personnel

13) Assist with facility repairs/maintenance with University of Chicago Plant personnel and vendors

14) Assist with instrumentation error reports and deviations

15) Perform duties as dictated by standard operating procedures (SOPs) for cellular product processing under Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed

16) Transport prepared vaccines/cell therapy products to the clinic or pharmacy

17) Maintain quality checks on facility operations including but not limited to testing and checking eyewash stations, changing gas tanks, biohazards and maintaining chemical inventory for University of Chicagoâ™s environmental health and safety

18) Perform all other duties as requested by the Technical Director or QA/QC Manager

Unit-specific Competencies

1) Working knowledge of Gâ™Xâ™P

2) 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

3) Must be able to manage multiple and rapidly changing priorities and have the ability to quickly learn new skills

4) Ability to demonstrate excellent interpersonal and communication skills; required

5) Strong emphasis on documentation according to FDA regulations and other regulating bodies

6) Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs

7) Excellent verbal and written communication skills

8) Capacity to exhibit organizational skills; required

9) Ability to work in a collaborative team environment

10) Capacity to handle multiple tasks and competing demands under tight timeframes

11) Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment

12) Ability to understand and carry out instructions and solve problems in complex situations

13) Ability to read and follow documents including protocols, batch records, and SOPs

14) Ability to independently learn new techniques

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

16) Excellent customer/staff interpersonal skills

Working Conditions

1) Ability to perform light/medium work, which includes lifting up to 30 pounds

2) Occasionally must bend, twist, squat, climb, reach, stoop, and kneel

3) Ability to be mobile walking from building to building

4) Ability to sit for some period of up to 2 hours

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

Preferred Qualifications

Education

1) Bachelor's degree in Science in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely related field

Experience

1) Requires a minimum of two years of laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field  
2) Advanced skills with Microsoft Office Suite

Required Documents

1) Resume

2) Cover letter

3) Reference contact information

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

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.