Process and Manufacturing Cell Therapy Specialist
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Chicago, IL 60664
- Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
20114 BSD Shared Research Facilities
- About the Unit
- Job Family
Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.
- Career Track and Job Level
Oversees all aspects of management, scientific technological development, and operations for major research projects or research facilities. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates. Writes articles, reports and manuscripts. Presents research findings at meetings and/or conferences.
P1: Performs routine assignments in the entry level to a professional job progression. Typically requires a college or university degree or the equivalent work experience that provides knowledge and exposure to fundamental theories, principles and concepts. Develops competence by performing structured work assignments. Uses existing procedures to solve routine or standard problems. Receives instruction, guidance and direction from others.
- Role Impact
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.
1) Maintains technical and administrative support for a research project., 2) Analyzes and maintains data and/or specimens. Conducts literature reviews. Assists with preparation of reports, manuscripts and other documents., 3) Installs, sets up and performs experiments; interacting with students and other laboratory staff under the direction of the principal investigator., 4) Maintains recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support. Has general awareness in research techniques or methods, regulatory policies and procedures, and relevant scientific field, 5) Performs other related work as needed.
Unit Specific Responsibilities
1) Support filing of the BLA Application for Islet Isolation including validation and qualification of processes, material and supplies, equipment and facility processes, produce and review technical documentation: SOPs, validations, batch records reports and other technical documents; perform vendor qualification of manufacturing supplies and material, and other tasks as required.
2) Performs manufacturing and/or processing of clinical trial products with an emphasis on cancer research and cellular therapy, following cGMP regulations and established SOPs.
3) Ability to manufacture using aseptic technique, manual dexterity for compounding sterile products, perform tissue culture, separation and preservation of serum and plasma from peripheral blood, analyzes blood cells by counting and identifying cells, using microscopic techniques.
4) Performs assays including but not limited to Endotoxin, Hemocytometer cells counts, and mycoplasma, collects and analyzes data, sets up and performs experiments and ensures operation of laboratory equipment by calibrating; completing preventive maintenance requirements; following manufacturer’s instructions; troubleshooting malfunctions; calling for repairs; maintaining equipment inventories; evaluating new equipment and techniques; troubleshoots, diagnoses and repairs any issues with the equipment used in the laboratory and/or cleanroom.
5) Prepares reports and other documents, prepares reports of technological findings by collecting, analyzing, and summarizing information.
6) Helps monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations.
7) Provides back-up with the daily operations of the cleanroom.
8) Tasks would include taking particle counts and preparing reports, Environmental Monitoring sampling, specialized cleaning of the facility, processing inventory and cleanroom garments, filing, document preparation (Standard Operating Procedures, logbooks and other specialized forms), kit preparation, and other miscellaneous assignments.
Unit Specific Competencies
1) Good communication skills.
2) Ability to handle confidential materials and information and follow written and verbal directions.
3) Scientific and technological problem-solving skills, reading, understanding and writing documents including protocol and SOPs.
4) Independently learning new techniques and flexible approach to working.
5) Strong attention to detail and good time management skills.
6) Basic math skills.
7) Multi-tasking skills.?
1) Operating a computer at a desk.
2) Using fine motor skills to operate/maintain instrumentation.
3) Light Lifting.
4) Limited walking.
5) Able to sit for some period of up to 2 hours
- Education, Experience, and Certifications
Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
1) Bachelor’s degree in a scientific field or medical technology
2) Advanced degree
1) Basic laboratory skills/techniques
2) Previous laboratory experience
3) Prior experience or working knowledge of G’X’P
2) Cover Letter
NOTE: When applying, all required documents **MUST**be uploaded under the Resume/CV section of the application.
- FLSA Status
- Pay Frequency
- Pay Grade
Depends on Qualifications
- Scheduled Weekly Hours
- Benefits Eligible
- Drug Test Required
- Health Screen Required
- Motor Vehicle Record Inquiry Required
- Posting Date
- Remove from Posting On or Before
- Posting Statement
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 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: 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.
- Posted 30+ Days Ago
- Full time