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Cell Therapy Specialist III-L (Lead), Manufacturing

United States - Maryland - FrederickManufacturing Operations & Supply ChainRegular

Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.

Kite is seeking Cell Therapy Specialist III-L to work in this exciting new area of cancer immunotherapy. Cell Therapy Specialist III-L will report into manufacturing supervisors and be responsible for supporting and executing manufacturing operations.

Responsibilities (include but are not limited to):

To be considered for this role, you must meet the following basic criteria:

  • Must be fully qualified in your current role

  • Must exhibit and demonstrate leadership attributes that align with the Gilead Core Values

  • Leadership experience is preferred

  • Must be willing and able to work any shift to ensure appropriate coverage for all operations

  • Must be in good standing with current performance and no disciplinary actions

  • Must demonstrate thorough process understanding and excellent cGMP, GDP and clean-room behavior

  • Ensure policies and procedures are consistently followed according to cGMP practices, SOP/EBR execution and all Gilead policies

  • Ensure that all aseptic behaviors and gowning practices are followed

  • Provide direct, timely feedback to staff and Supervisor on issues that arise on the floor

  • Monitor floor performance and provide feedback to those deviating from procedures

  • Work with supervisor and other team leads to manage and prioritize staffing assignments to ensure production schedule is met

  • Use basic problem-solving skills to ensure stable operations and escalate appropriately

  • Serve as the front-line defense in assessing events that should be elevated as a process comment or deviation

  • Guides, teach and mentor staff on performing tasks while maintaining a high level of quality and compliance

  • Assist area operations with real time review of all associated GMP documentation

  • Work closely with support staff such as Quality Assurance, Site Manufacturing Technology, MSAT, and QC to resolve issues or participate in cross functional teams

  • Identify and support continuous improvement efforts with Manufacturing Supervisor

  • Participate and lead shift meetings and daily huddles

Basic Qualifications:

  • Bachelor’s Degree in Biochemical Engineering, Biotechnology or Life Sciences with 2+ years of biotech experience or

  • Associates Degree in Biochemical Engineering, Biotechnology or Life Sciences with 4+ years of biotech experience or

  • High School Diploma with 5+ years of biotech experience

Preferred Qualifications:

  • Knowledge of pharmaceutical manufacturing, preferably cell culture

  • Ability to provide solutions to moderately complex to semi-routine problems.

  • Excellent verbal, written, and interpersonal communication skills.

  • Excellent computer, organizational, and project management skills.

  • Ability to recognize deviation from accepted practice.

  • Ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

  • Ability to communicate effectively with peers in organization.

  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles

  • Ability to adapt in a constantly evolving environment