
Cell Therapy Specialist III-L (Lead), Manufacturing
United States - Maryland - FrederickManufacturing Operations & Supply ChainRegularJob 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