We are seeking highly motivated Cell Therapy Specialists II to join our newly formed Cell Therapy Manufacturing team at Kite’s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.

The Cell Therapy Specialist II will 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 as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.

Are you passionate about making an impact on people’s lives? Would you be excited to work for a company leading the way in developing and producing unique, innovative immunotherapies? Do you have a background in cGMP manufacturing? If the answer is yes, we’d like to consider you!

Responsibilities of the Cell Therapy Specialist II include:

• Successfully troubleshoots processing and equipment issues while communicating said issues to management

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

• Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations

• Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms

• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls

Basic Requirements:

BA / BS Degree

OR

AA Degree with 2+ years of cGMP experience

OR

High School Degree and 3+ years of cGMP experience

Preferred Qualifications

• 3+ years of cGMP experience with a pharmaceutical / biotechnology or similar manufacturing environment

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

• Confirmed knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture and/or vector products

• Excellent aseptic/sterile techniques while working in Grade A and Grade B clean rooms

• Experience in handling and propagation of human primary cells, including T cells; previous experience with cell therapy products or vector products preferred

• 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

• Ability to work off-shift and extra hours as required

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

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