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Cell Therapy Specialist

United States - Maryland- GaithersburgManufacturing Operations & Supply ChainRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated Cell Therapy Specialist at our clinical production facility in Gaithersburg, Maryland. The facility is being developed as a Center of Excellence for the advancement of novel TCR mediated T cell therapies targeting tumor mutations and antigens. Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of our commercial cell therapies.

Responsibilities include, but are not limited to:

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

  • Work as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance

  • Perform set-up, operation, cleaning, basic maintenance, and break down of simple/routine equipment as per applicable SOPs

  • Raise processing and equipment issues in timely manner to manufacturing management and actively participate in troubleshooting

  • Complete required training assignments to maintain necessary technical skills, knowledge and to ensure compliance with cGMP requirements

  • Assist in the development of SOPs and batch records

  • Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities

Basic Requirements:

BA / BS Degree

OR

High School Degree with 2+ years of cGMP manufacturing experience

Preferred Skills:

  • Minimum of 1+ years of cGMP experience preferred; pharmaceutical / biotechnology or similar manufacturing environment

  • Previous experience with cell therapy or vector products

  • Aseptic processing and cell culture processing in combination with cell culture equipment experience

  • ​Experience in handling and propagation of human primary cells, including T cells

  • Rigorous adherence to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with commercial manufacturing

  • Experience with automated processing equipment

  • Skills in Microsoft Word and Excel

  • Ability to think critically with validated troubleshooting and analytical skills

  • Ambitious and willing to accept temporary responsibilities outside of initial job description

  • Excellent interpersonal, verbal and written communication skills that are critical in this collaborative work environment

  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you?! If so, apply today.

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