GMP Manufacturing Specialist I

Senior Professional Technical Recruiter at Apex Systems

GMP Manufacturing Specialist I

Position Description

The GMP Manufacturing Specialist I will work closely with GMP Manufacturing team in developing and executing cGMP manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Specialist I will assist in technology transfer of manufacturing processes internally and to external collaborators. Duties will include raw material ordering, inventory management, raw material preparations (e.g media, buffers etc.), assisting in cell manufacturing process, writing standard operating procedures (SOPs), and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.

Responsibilities

• Perform duties as dictated by standard operating procedures for cell manufacturing and under cGMP guidelines as directed
• Perform...