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Cell Therapy Manufacturing Specialist

2 months ago

Frederick, Maryland, United States Innova Solutions Full time

Job Summary:

Innova Solutions is seeking a highly skilled Cell Therapy Specialist to join our team at our state-of-the-art commercial Cell Therapy facility in Maryland. As a Cell Therapy Specialist, you 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, provides clear instructions to align with cGMP requirements and supports 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
  • OR AA Degree with 1+ years of cGMP experience
  • OR High School Degree and 2+ years of cGMP experience

Benefits:

  • Medical & pharmacy coverage
  • Dental/vision insurance
  • 401(k)
  • Health saving account (HSA) and Flexible spending account (FSA)
  • Life Insurance
  • Pet Insurance
  • Short term and Long term Disability
  • Accident & Critical illness coverage
  • Pre-paid legal & ID theft protection
  • Sick time, and other types of paid leaves (as required by law)
  • Employee Assistance Program (EAP)