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
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.
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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