Cell Therapy Manufacturing Specialist

4 days ago


Frederick, Maryland, United States Fladger Assoc. Inc. Full time
Job Summary

Fladger Assoc. Inc. is seeking a highly skilled Cell Therapy Specialist I to join our team in Frederick, MD. As a key member of our manufacturing team, you will be responsible for the production of clinical and commercial products following strict quality control procedures.

Key Responsibilities:
  • Manufacture clinical and commercial products in a cGMP environment
  • Collaborate with Process Development and Quality teams to execute GMP runs
  • Develop and maintain standard operating procedures, batch records, and deviations
  • Troubleshoot processing and equipment issues
  • Perform other duties as assigned
Requirements:
  • Associates degree or high school diploma with industry experience, or bachelor's degree and/or advanced degree
  • Cell culture processing experience
  • Previous experience with cell therapy products is a plus
  • Demonstrated knowledge of pharmaceutical manufacturing, aseptic processing, and cell culture products
  • Strict adherence to SOPs and cGMP regulations
  • Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment
  • Experience with handling and propagation of human primary cells, including T cells
  • Excellent skill in Microsoft Word, Excel, and data analysis
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities
  • Ability to work off-shift and extra hours as required


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