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 Operational Excellence Lead as part of the Technical Operations team based in Raritan, NJ.
This position will be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to establish a strong continuous improvement and problem-solving culture and project management office to enable robust production, testing and release of product to patients.
- Plans, leads, develops, provides expertise, trains, coaches, drives and manages an effective, holistic continuous improvement, problem solving and project management program to improve safety, compliance, cost, process stability, building quality and efficiency into processes to improve lead times and reliability in delivery to patients.
- Implement a continuous improvement program throu.gh the use of lean and six sigma manufacturing methodologies such as standard and standardized work, daily management system (e.g. tier process), metrics, visual tools, PDCA, Kanban, pull systems, SMED, pareto, FMEA and others.
- Implement the routine use of disciplined problem solving such as DMAIC.
- Lead a junior team of operational excellence members and the risk assessment team.
- Develop, teach, implement and coach the effective use of tools such as kata methodology, A3 thinking, 4Ups, 6S and others.
- Lead and teach others to lead and participate in kaizen events.
- Facilitate, lead and teach others to participate and lead value steam analysis events.
- Implement strategic thinking with hoshin planning.
- Apply and teach change management methodology in all aspects of the plant operational excellence efforts.
- Engage Plant Leadership Team and other functional plant leaders to embody a continuous improvement culture.
- Ability to interact with all levels within the organization:
Operations, Quality, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering
- BS/BA required in technical discipline: Engineering, science or similar field.
- Lean Six Sigma Green or Black Belt preferred.
- PMP certification preferred.
- Experience in several operational functions, e.g. Manufacturing, Quality, Supply Chain, Technical Operations.
- Toyota Production System training and application.
- Demonstrated ability to build effective and efficient teams and drive change within an organization.
- Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.
- A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning.
- Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations.
- Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment.
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels.
- Lean background.
- Ability to engage all levels of the organization, from site leadership to the shop floor in continuous improvement.
- Proven experience working and leading in a matrix environment.
- Ability to lead with influence.
- cGMP manufacturing.
- 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 and critical thinking skills.
- Project management.
- Change management.
- Excellent organizational and communication skills.
- Transparent, Passionate, Fearless and Accountable.
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.