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Cell Therapy Manufacturing Specialist

2 months ago

Frederick, Maryland, United States ATR International Full time
Job Overview

ATR International is seeking a highly motivated Cell Therapy Specialist to join our Cell Therapy Manufacturing team at our state-of-the-art facility in Maryland.

Key Responsibilities:

  • Perform and/or verify tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.
  • Work as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control, and Quality Assurance.
  • Successfully troubleshoot processing and equipment issues while communicating said issues to management.
  • Complete required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
  • Author and/or revise SOPs that are technically sound, provide clear instructions to align with cGMP requirements, and support efficient operations.
  • Routinely monitor, clean, prepare, and operate sophisticated automated cell processing, cell expansion, and filling equipment in Grade B/C clean rooms.
  • Finding opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls.

Basic Requirements:

  • BA/BS Degree in Sciences Field
  • OR
  • AA Degree with 1+ years of cGMP experience