Clinical Research Coordinator II – Cellular Manufacturing

University of Chicago•Chicago, IL

10d•Onsite

About The Position

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. As a Clinical Research Coordinator II – Cellular Manufacturing, you will work in a state-of-the-art cleanroom within the UChicago Cellular and Tissue-Based Processing cGMP Facility, supporting the manufacture of clinical-grade cellular therapies and vaccines for Phase I–III trials. You will perform aseptic processing, execute complex protocol-driven manufacturing procedures, and maintain accurate batch records and documentation. Additional responsibilities include supporting deviation investigations and CAPA, managing inventory and materials, and training junior staff. Reporting to the Technical Director, you will help lead daily ISO 7 cleanroom operations, oversee equipment maintenance and troubleshooting, and ensure strict adherence to cGMP and regulatory standards. Strong expertise in aseptic technique, ISO 7 gowning, and complex cell processing and analytical assays is required.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Strong expertise in aseptic technique, ISO 7 gowning, and complex cell processing and analytical assays is required.

Nice To Haves

Masters Degree in related field.
4 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a related field strongly preferred.
Knowledge of 21 CFR Parts 210 and 211 strongly preferred.
Prior experience in cGMP manufacturing or pharmacy compounding strongly preferred.
Prior experience in cell culture, analytical assay performance and development, viral gene transduction, and sterile filling techniques strongly preferred.
Advanced skills with Microsoft Office Suite strongly preferred.
Medical Lab Technician Certification-MLT (ASCP) strongly preferred.
Pharmacy Technician Certification-CPhT strongly preferred.
Working knowledge of GxP, CLIA, CAP, and FDA-regulated environments.
Experience in cGMP sterile cleanroom operations.
Ability to follow and execute SOPs, protocols, and batch records.
Strong documentation practices and attention to detail.
Excellent verbal and written communication skills.
Strong interpersonal skills with ability to collaborate across teams and interact professionally with all staff while maintaining confidentiality.
Highly organized with the ability to manage multiple priorities and meet tight deadlines in a fast-paced environment.
Problem-solving skills with the ability to understand, retain, and apply complex instructions.
Self-motivated with the ability to learn new techniques quickly and work independently.

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.
Transport prepared vaccines/cell therapy products to the clinic or pharmacy.
Perform and support Cell Therapy assays (including CAP proficiency/competency) in accordance with SOPs and best practices.
Execute SOPs to support facility and operational needs.
Assist with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance, monitoring, and troubleshooting.
Support cGMP compliance through validation and qualification of processes, materials, equipment, and vendors.
Ensure proper handling and storage of materials and samples under required conditions.
Document and report instrumentation errors, deviations, and quality events.
Support compliance with institutional, state, and federal regulations, as well as accrediting body requirements.
Perform GMP-compliant room changeovers and specialized cleaning between campaigns.
Manage ordering and inventory of supplies.
Train and guide new staff.
Complete required training and adhere to all safety and operational procedures.
Accountable for all tasks in moderately complex clinical studies.
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 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.