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Jul 24 2020

Administrative Cell Therapy Specialist

Kite Pharma Santa Monica, California, United States

Cell Therapy Specialist

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. Would you like to join us in this mission?

We are seeking a highly motivated Cell Therapy Specialist to support our new commercial Cell Therapy biotechnology facility in Frederick, MD. Under minimal supervision, in this role you will be accountable for and passionate about 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
  • Successfully troubleshoot processing and equipment issues. Communicate effectively with management for any processing or equipment issues.
  • Complete required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
  • Author or revise SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations.
  • Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms
  • Find opportunities for improvement in manufacturing efficiencies and compliance. Assist with investigations/deviations and change controls
  • Other duties as assigned

Requirements

  • High school degree and 3+ years of experience required. Bachelor’s degree preferred.
  • Minimum of 3+ years of cGMP experience required; pharmaceutical / biotechnology or similar manufacturing environment is preferred.

Preferred qualifications

  • Aseptic processing and cell culture processing in combination with cell culture equipment experience
  • Excellent aseptic/sterile techniques while working in Grade A and Grade B clean room
  • Experience in handling and propagation of human primary cells, including T cells; previous experience with cell therapy products or vector products preferred
  • Confirmed knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture and/or vector products
  • Adhere 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, Excel and data analysis
  • Demonstrated ability to think critically with proven 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 essential 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
  • You have the ability to work off-shift and extra hours as required

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

To apply, visit: https://gilead.wd1.myworkdayjobs.com/en-US/kitepharmacareers/job/United-States—Maryland—Frederick/Cell-Therapy-Specialist_R0013732-1

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Job Categories: Full-Time. Job Types: Administrative.

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