GMP Manufacturing Specialist

4 weeks ago


Frederick, Maryland, United States Intelliswift Software Inc Full time

Job Summary

The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.

This role will work as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.

Key Responsibilities

  • Successfully troubleshoots processing and equipment issues while communicating said issues to management
  • Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
  • Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and support efficient operations
  • Routinely monitors, cleans, prepares, and operates sophisticated automated cell processing, cell expansion, and filling equipment in Grade B/C clean rooms
  • Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls

Basic Requirements

  • BA / BS Degree in Sciences Field
  • AA Degree with 1+ years of cGMP experience
  • High School Degree and 2+ years of cGMP experience


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