
Cell Therapy Specialist I
United States - California - Santa MonicaManufacturing Operations & Supply ChainRegularJob Description
Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. The Cell Therapy Specialist will be responsible for cell culture media preparation, cell processing and cell expansion in a cGMP clinical manufacturing facility.
Responsibilities:
- Perform all tasks associated with the manufacture of clinical product following batch records and SOPs
- Work as part of a small team to execute GMP runs in close collaboration with Product Sciences and Quality
- Assist in the development of standard operating procedures, batch records, deviations and change controls
- Successfully troubleshoot processing and equipment issues
- Work with flexible schedule, and work overtime as needed
Basic Qualifications:
- AA degree and 1+ years’ experience in manufacturing, or pharmaceutical / biotechnology industry OR
- High School degree and 2+ years’ of experience in manufacturing, or pharmaceutical / biotechnology industry
- Physical Requirements:
- Ability to lift over 30 lbs.
- Stand, walk, squat, bend, kneel, climb, and or reach for 75% of a shift
Preferred Qualifications:
- Bachelor’s degree and 2+ years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment
- Cell culture processing experience
- Experience with cell therapy products
- 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 or commercial manufacturing
- Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Wave bioreactors
- Experience with handling and propagation of human primary cells, including T cells
- Experience with working in a clean room environment (ISO 8, ISO 7, ISO 5)
- Excellent skill in Microsoft word, Excel and data analysis
- Demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to work standing/walking for several hours