Cellular Manufacturing Clinical Research Coordinator II

University of Chicago; Chicago (IL); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Job summary

The University of Chicago is seeking a Clinical Research Coordinator II – Cellular Manufacturing to work in a state-of-the-art cleanroom supporting the manufacture of clinical-grade cellular therapies for Phase I–III trials.

You will perform aseptic processing, execute protocol-driven manufacturing procedures, maintain batch records, and support deviation investigations, CAPA, and inventory management while training junior staff.

Qualifications

• 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.

Responsibilities

• Perform a variety of cellular product processing procedures under G’X’P guidelines with speed and accuracy.
• Perform a variety of cellular infusion procedures under GTP guidelines with speed and accuracy.
• Perform and support cell therapy assays in accordance with SOPs and best practices.
• Maintain accurate batch records and documentation.
• Support deviation investigations and CAPA, and manage inventory and materials.
• Train and guide new staff and ensure compliance with regulatory standards.

Skills

Aseptic technique

Documentation

Team training

CAPA investigations

Education

Masters Degree in related field

Bachelor's degree in related field

Tools

Microsoft Office Suite

Job description

The University of Chicago is seeking a Clinical Research Coordinator II – Cellular Manufacturing to work in a state-of-the-art cleanroom supporting the manufacture of clinical-grade cellular therapies for Phase I–III trials.

You will perform aseptic processing, execute protocol-driven manufacturing procedures, maintain batch records, and support deviation investigations, CAPA, and inventory management while training junior staff.