CAR-T Operations Resource Scheduler

Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
The CAR-T Operations Resource Scheduler is an exempt level position working within Technical Operations team, responsible for scheduling the training and the staffing of the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.
Responsibilities

• The CAR-T Operations Resource Scheduler will schedule the operators of multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• The CAR-T Operations Resource Scheduler will discuss the schedule with the CAR-T Operations Supervisor on a frequent basis and highlight the planning risks, enabling the CAR-T Operations Resource Scheduler to mitigate well in advance and ensure business continuity.
• The CAR-T Operations Resource Scheduler will attend the planning meetings (short and mid long term) to anticipate the operational resource need and discuss this with the CAR-T Operations Supervisor/Manager
• The CAR-T Operations Resource Scheduler will prepare the long term shift schedule for the operators well in in advance, allowing the operators to plan accordingly
• The CAR-T Operations Resource Scheduler will schedule the detailed schedule 1 week in advance
• The CAR-T Operations Resource Scheduler will also schedule the operators for their individual training sessions linked to their onboarding and training program, together with the training department which will provide the training slots.
• The CAR-T Operations Resource Scheduler is responsible of making sure that the Training curricula of a CAR-T Operator is matching with the job specific tasks
• Once sufficiently trained, the CAR-T Operations Scheduler can schedule in the operators to support/execute the CAR-T Process according to the procedure
• Support the follow up of the training and qualification status of production personnel
• The Scheduler will need to build strong partnerships with Training department, Supply Chain Planning, QC IPL, Facilities & Engineering, Maintenance to ensure seamless execution of the training program, CAR-T process and maintenance.
• Attend the daily tier meeting within operations and follow up that individuals adhere to their daily production task to execute and ensure compliance and successful completion of work-related tasks
• Work in a constructive and flexible way in a team
  

Qualification
Education:

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
  

Experience:

• A minimum of 3 years of operational experience within a GMP environment, preferably in a scientific/pharmaceutical industry (bachelor degree)
• A minimum of 1 year of operational experience within a GMP environment, preferably in a scientific/pharmaceutical industry (master degree)
  

Capabilities, Knowledge, And Skills

• Must exhibit ability to effectively communicate and influence Operations associate and convey information to Management.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving, pragmatic, structural and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Can do attitude, Right first time and Hands-on approach
• Tenacity to drive issues until resolved and deliver results
• Self-motivated, enthusiastic personality, team player
• Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Excellent communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice
  

Language
Dutch and English
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.