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 and natural killer (NK) cell-based immunotherapy. 

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

This position will be responsible for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for owning, driving and delivering cost saving and/or efficiency improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require lean leadership and disciplined problem solving and effective continuous improvement via communication, coordination and collaboration across relevant cross functional groups to establish a strong culture that enables robust production, testing and release of product to patients.

Key Responsibilities  

• Owns, plans, leads, Develops, drives and executes against an effective, holistic continuous improvement and problem-solving program to improve safety, compliance, cost, process stability building quality and efficiency into processes to improve lead times and reliability in delivery to patients.
•  Executes the defined continuous improvement program through the use of lean and six sigma manufacturing methodologies such as standard and standardized work, metrics, visual tools, PDCA, Kanban, pull systems, SMED, pareto, FMEA, A3 thinking, time studies, poke yoke, process mapping and others.  
• Implements the routine use of disciplined problem solving such as DMAIC.
• Leads, facilitates, and participates in kaizen events.
• Manages the implementation of continuous improvement projects as needed.
• Participates in value steam analysis and hoshin planning events.
• Performs voice of the customer (VOC) via process capability and defect elimination.
• Applies change management methodology in all aspects of the plant operational excellence efforts Engage functional plant leaders to embody a continuous improvement culture.

Requirements

• BS/BA in technical discipline (Engineering, Science, or similar) strongly preferred. Those without degrees or those with degrees in non-technical disciplines can be considered after exceptional performance and an additional 4 years of experience leading and supporting continuous improvement efforts beyond the requirement for BS/BA. A High School diploma (or equivalent) is required, without exception.
• Minimum 3-7 years of experience leading and/or supporting continuous improvement efforts in a manufacturing environment with BS/BA in technical discipline: Engineering, Science, or similar field.
• Minimum 2-5 years of experience leading and/or supporting continuous improvement efforts in a manufacturing environment with MS in technical discipline: Engineering, Science, or similar field.
• Strong understanding and proven application of problem-solving tools and techniques such as LEAN and Six Sigma in a manufacturing environment.
• Six Sigma greenbelt or LEAN Bronze preferred. Certification by reputable 3rd party organizations (i.e. ASQ, Society of Manufacturing Engineers) desirable.
• Experience implementing LEAN tools or Six Sigma methodology in a manufacturing environment 6. Strong understanding and proven application of problem-solving tools and techniques in a manufacturing environment.
• Knowledge of the CAR-T manufacturing process desirable.
•  Ability to engage all levels of the organization, from site leadership to the shop floor.
• Proven experience working and leading in a matrix environment.
• Ability work with passion and influence.
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Strong analytical, problem solving and critical thinking skills.
• Effective change management skills.
• Ability to quickly learn and analyze new processes and systems.
• Excellent organizational and communication skills.
• Hybrid Role. Minimum 3 days onsite / week.  Must be willing to come onsite additional days when job responsibilities require.

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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.