Cell Therapy Production Specialist

7 days 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 play a critical role in the manufacture of commercial products, ensuring safe and compliant operations.

Key Responsibilities:

  • Perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs)
  • 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
  • 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)


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