Job Description:

• Perform a variety of cellular product processing procedures under Gâ™Xâ™P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy.

• Perform a variety of cellular infusion procedures under GTP guidelines as directed with speed and accuracy.

• Perform a variety of special manufacturing projects under cGMP guidelines as directed with speed and accuracy.

• Provide backup support to a variety of cellular product projects to the Advanced Cellular Therapeutics Facility.

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

• Perform various assays including but not limited to CAP proficiency and competency assays as needed for Cell Therapy processes.

• Perform various assays as needed for Cellular Therapy product processes to standard best practices.

• Perform various standard operating procedures as needed for facility operations.

• Assist in the set-up of new equipment and assist with upkeep such as 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 materials and samples are stored correctly at the right temperature.

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

• Assist in instrumentation error reports and deviations.

• Perform room change-over in facility after campaigns with specialized cleaning to maintain cGMP compliance.

• 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.

• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

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

• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.

• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.

• Performs other related work as needed.

Preferred Qualifications

Education:

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

• Advanced degree.

Experience:

• Requires a minimum of 2 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field.

• A related masterâ™s degree may offset required years of experience at 1:1 (i.e. a two-year masterâ™s degree in lieu of two years of experience).

• Prior experience in cell culture, analytical assay performance and development, viral gene transduction, and sterile filling techniques are high desirable.

• Advanced skills with Microsoft Office Suite.

Preferred Competencies

• Working knowledge of Gâ™Xâ™P.

• Working knowledge of CLIA and CAP.

• 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 lead operation to 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.

Working Conditions

Application Documents

• Resume (required)

• Cover Letter (preferred)

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.

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