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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 facilit 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 designate