Department
BSD SRF - cGMP
About the Department
Job Summary
The job compiles, documents, analyzes, and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Under the supervision of the Technical Director of the cGMP Core, this position requires the candidate to collaborate within a team atmosphere that prepares/process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility, including tasks related to maintaining the facility operations. This position requires the candidate to adhere to 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
Perform a variety of cellular product processing procedures under G’X’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.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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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 master’s degree may offset required years of experience at 1:1 (i.e. a two-year master’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 G’X’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
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.
Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills.
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 long hours depending on the study-specific procedure (2 to 4 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
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
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
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.
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