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 Summary

The job performs routine assignments related to scientific research projects. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates. Analyzes possible solutions using standard procedures. Writes articles, reports and manuscripts. Assists in drafting presentations on research findings.

Under the supervision of the Technical Director and facility manager of the cGMP Core, this position requires the candidate to collaborate within a team atmosphere that process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility. This position requires the candidate to adhere to sponsored clinical trial protocols and standard operating procedures as well as working off hours at times. The ideal candidate will need to be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping. This candidate will be required to juggle multiple/competing priorities and also be assigned back up duties to support facility operations. The candidate must be open to undergoing and pass rigorous training with respect to cGMP and USP standards as well as various technical assays and procedures specific for various cellular manipulation techniques.

Responsibilities

Quality Control and Validation:

Perform environmental monitoring in the Production Areas including but not limited to: dynamic monitoring for campaigns, biweekly particle counts and monthly air samples and prepare reports.

Perform personnel monitoring for required campaigns.

Assist in the set up new lab equipment used in Quality Control Laboratory and assist with upkeep such as setup, temperature monitoring, daily verification with QC, instrument/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting.

Support cGMP compliance through validation and qualification of processes, material and supplies, equipment, and facility processes, perform vendor qualification of manufacturing supplies and material.

Ensure all equipment are operating correctly.

Ensure all materials and samples are stored correctly at the right temperatures.

Facility Operations:

Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.

Process supply orders on Buysite and through pharmacy, processes inventory-obtain quality certificates for all items.

Prepare kits of supplies used in manufacturing for all campaigns.

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

Assist in facility expansion projects with the Technical Director and Facility Manager.

Assist in instrumentation error reports and deviations.

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

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

Attend all required training and comply with all safety and operations procedures.

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

Cellular Processing and Manufacturing:

Provide backup support to variety of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.

Provide backup support to variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.

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

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.

Assists with various professional, organizational, and operational tasks under direct supervision.

Supports quality assurance reviews conducted by study sponsors, federal agencies, or specifically designated review groups.

Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

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

Bachelor’s of science degree in biological or physical sciences.

Graduate degree.

Experience:

2-3 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, cell biology, or a related field.

Previous experience in mammalian cell and tissue culture, molecular biology, and viral gene transduction.

Previous experience in equipment maintenance and validation.

Working knowledge of quality control and cGMP.

Advanced skills with Microsoft Office Suite.

Preferred Competencies

Ability to work in a cGMP sterile clean room setting.

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 including Batch Records and SOPs.

Attention to detail.

Ability to demonstrate excellent interpersonal and communication skills.

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

Excellent verbal and written communication skills.

Capacity to exhibit organizational skills.

Ability to work in a collaborative team environment.

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

Ability to understand, retain, and carry out instructions and solve problems in complex situations.

Ability to independently learn new techniques.

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

Excellent customer/staff interpersonal skills.

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 as well as independently.

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

Working Conditions

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.

Application Documents

Resume (required)

Cover Letter (preferred)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required
 

Yes

Health Screen Required
 

Yes

Motor Vehicle Record Inquiry Required
 

No

Pay Rate Type

Salary

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FLSA Status

Exempt

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Pay Range

$47,500.00 - $71,500.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement
 

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or 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 Applicant Inquiry Form.

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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: http://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.