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, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). 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. Operational Excellence 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 proven lean leadership and expertise that drives 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, provides expertise, trains, coaches, 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 DMAIC, standard and standardized work, metrics, visual tools, PDCA, Kanban, pull systems, SMED, pareto, FMEA, A3 thinking, time studies, poke yoke, process mapping and others.
- Leads, facilitates and teaches others to lead and participate in kaizen events and increase continuous improvement skills.
- Facilitates in value steam analysis and hoshin planning events.
- Mentors selected plant team members to become yellow or green belts.
- Performs voice of the customer (VOC) via process capability and defect elimination.
- Applies and teaches change management methodology in all aspects of the plant operational excellence efforts.
- Routinely engages functional plant leaders to develop a continuous improvement culture.
- With respect to the coaching of others to upskill, you have the authority to make decisions regarding approach and methodology.
- With respect to cost savings initiatives, have the authority to engage with appropriate departments to define the problem, map out the current state and the future state, obtain alignment, and request resources from PMO. PMO requests should be reviewed by direct supervision prior to submission.
- With respect to larger continuous improvement system implementation and improvements, you have the authority to engage with functions as needed and develop continuous improvement system implementation approach. Strategic shifts or major collaborations must be reviewed by direct supervisor prior to commencing.
Requirements
- BS in engineering required. M.S. in engineering or MBA desirable.
- Minimum 10+ years of experience leading and supporting continuous improvement efforts in a manufacturing environment with BS in Engineering.
- Minimum 8+ years of experience leading and supporting continuous improvement efforts in a manufacturing environment with MS in Engineering or MBA.
- Has driven to completion numerous, significant cost savings or efficiency gains in multiple functions (Production, Engineering, Facilities, Maintenance, QA, QC, etc.).
- Proven knowledge and demonstrated experience of designing, leading, implementing, and operating tiered meetings inclusive of KPIs and metrics, problem solving and driving improvement.
- Has implemented systems that support a culture of continuous improvement.
- Six Sigma Black Belt (with projects) required. Certification by reputable 3rd party organizations (i.e. ASQ, Society of Manufacturing Engineers) desirable.
- Routine application of Lean and Six Sigma problem solving tools and techniques to drive substantial business results.
- Superior knowledge and demonstrated execution of continuous improvement and lean tools and techniques.
- Advanced Proficiency with Excel – Pivot Tables, etc.
- Basic Proficiency with Process Mapping Software – Visio, etc.
- Basic Proficiency with Statistical Analysis Software – Minitab (Preferred), JMP, etc.
#Li-BZ1
#Li-Onsite
The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits
Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Top Skills
What We Do
Legend Biotech is a global, commercial-stage biotechnology company developing and manufacturing novel therapies. We explore and apply innovative technologies to deliver cutting-edge options for patients around the world.
Our corporate headquarters is located in Somerset, NJ, and our manufacturing footprint includes facilities in the United States, China and the Belgium.
