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GMP Manufacturing Specialist

2 months ago

Frederick, Maryland, United States Intelliswift Software Full time
Cell Therapy Specialist Job Description

Job Summary: We are seeking a highly skilled Cell Therapy Specialist to join our team at Intelliswift Software. The successful candidate will be responsible for performing and/or verifying all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.

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, provide 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

Requirements:

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

Working Environment: The Cell Therapy Specialist will work in a fast-paced, dynamic environment with a team of experienced professionals. The ideal candidate will be able to work independently and as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control, and Quality Assurance.