Cell Therapy Specialist I

4 weeks ago

Frederick, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionFrederick, MDContract Duration: 6-18 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Cell Therapy Specialist I in the Frederick, MD area.
  • Perform all tasks associated with the manufacture of clinical and commercial product following batch records and SOPs
  • Work as part of a team to execute GMP runs in close collaboration with Process Development and Quality Assist in the development of standard operating procedures, batch records, deviations and change controls
  • Successfully troubleshoot processing and equipment issues
  • Other duties as assigned.

Experience:

  • Associates Degrees or High School Diploma with industry experience, Bachelor's Degree and/or advanced Degree or 3 or more years of cGMP experience in a Manufacturing Pharmaceutical/Biotechnology environment.
  • Cell culture processing experience
  • Previous experience with cell therapy products is a plus
  • Demonstrated knowledge of Pharmaceutical Manufacturing of Biotechnology products, aseptic processing, cell culture products
  • Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
  • 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 demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
  • Ability to work off-shift and extra hours as required

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