Continuous Improvement Facilitator
Legend Biotech
4 hours ago
On-site
Raritan, NJ
Operations
Role Overview
This position provides operational excellence support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
The Continuous Improvement Facilitator leads and supports continuous improvement initiatives for CAR-T Manufacturing, identifying improvement opportunities, implementing structured problem-solving methodologies, and driving sustainable operational improvements.
Key Responsibilities
- Support planning, development, and execution of continuous improvement initiatives using Lean and Six Sigma methodologies (standardized work, PDCA, metrics, visual tools, 5S/6S, FMEA, Pareto analysis, etc.) to improve safety, compliance, cost, process stability, and efficiency.
- Design and implement data collection systems for operational performance monitoring and CI initiatives; use Power BI and Power Automate to automate workflows and visualize KPIs.
- Facilitate and lead Kaizen events and improvement workshops to improve process performance, reduce waste, drive right-first-time execution, and increase productivity.
- Lead/support value stream mapping to identify bottlenecks and inefficiencies and develop improvement plans.
- Deliver training on Lean tools, techniques, and methodologies.
- Support implementation of key CI projects (tracking progress, managing resources, reporting outcomes).
- Track and measure CI impact using relevant metrics/KPIs and provide updates to leadership.
- Apply and coach change management principles to support adoption and sustainment.
- Partner with Operational Excellence and the Project Management Office to implement improvements.
Requirements
- BS/BA in Engineering, Science, or similar technical discipline.
- Lean Six Sigma Green preferred.
- Experience in GMP Manufacturing, Quality, and/or Supply Chain in biotech/biopharma; cell/gene therapy cGMP manufacturing preferred.
- Minimum 2 years leading and/or supporting continuous improvement/operational excellence/process improvement in a manufacturing or regulated environment (e.g., cGMP).
- Knowledge of Lean and/or Six Sigma and practical application to operational environments (Manufacturing, Quality, Supply Chain).
- Experience facilitating Kaizen events and value stream mapping.
- Strong problem-solving tools and techniques.
- Ability to engage all levels (site leadership to shop floor) and lead in a matrix environment.
- Excellent communication/interpersonal/team-building skills; able to influence at all levels.
- Ability to manage shifting priorities and meet deadlines in a fast-paced environment.
- Strong ownership; ability to work independently.
- Strong analytical, problem-solving, and critical thinking skills.
- Proficiency in Microsoft Office (Excel, PowerPoint, Word); MS Teams/Power BI/Power Automate preferred.
- Knowledge of cGMP regulations and FDA guidance related to cell-based product manufacturing.
- Solution-oriented mindset; ability to develop new procedures/alternate paths for improvement.
Benefits (as stated)
- Base pay range: $93,463–$122,670 (USD).
- Performance-based bonus and/or equity (eligible roles).
- Medical, dental, vision; 401(k) with company match (vests day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off: vacation, personal time, sick time, floating holidays, and 11 company holidays.
- Additional voluntary benefits: flexible spending/HSA, life & AD&D, short-/long-term disability, legal assistance, supplemental plans (pet, critical illness, accident, hospital indemnity), commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.
This position provides operational excellence support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
The Continuous Improvement Facilitator leads and supports continuous improvement initiatives for CAR-T Manufacturing, identifying improvement opportunities, implementing structured problem-solving methodologies, and driving sustainable operational improvements.
Key Responsibilities
- Support planning, development, and execution of continuous improvement initiatives using Lean and Six Sigma methodologies (standardized work, PDCA, metrics, visual tools, 5S/6S, FMEA, Pareto analysis, etc.) to improve safety, compliance, cost, process stability, and efficiency.
- Design and implement data collection systems for operational performance monitoring and CI initiatives; use Power BI and Power Automate to automate workflows and visualize KPIs.
- Facilitate and lead Kaizen events and improvement workshops to improve process performance, reduce waste, drive right-first-time execution, and increase productivity.
- Lead/support value stream mapping to identify bottlenecks and inefficiencies and develop improvement plans.
- Deliver training on Lean tools, techniques, and methodologies.
- Support implementation of key CI projects (tracking progress, managing resources, reporting outcomes).
- Track and measure CI impact using relevant metrics/KPIs and provide updates to leadership.
- Apply and coach change management principles to support adoption and sustainment.
- Partner with Operational Excellence and the Project Management Office to implement improvements.
Requirements
- BS/BA in Engineering, Science, or similar technical discipline.
- Lean Six Sigma Green preferred.
- Experience in GMP Manufacturing, Quality, and/or Supply Chain in biotech/biopharma; cell/gene therapy cGMP manufacturing preferred.
- Minimum 2 years leading and/or supporting continuous improvement/operational excellence/process improvement in a manufacturing or regulated environment (e.g., cGMP).
- Knowledge of Lean and/or Six Sigma and practical application to operational environments (Manufacturing, Quality, Supply Chain).
- Experience facilitating Kaizen events and value stream mapping.
- Strong problem-solving tools and techniques.
- Ability to engage all levels (site leadership to shop floor) and lead in a matrix environment.
- Excellent communication/interpersonal/team-building skills; able to influence at all levels.
- Ability to manage shifting priorities and meet deadlines in a fast-paced environment.
- Strong ownership; ability to work independently.
- Strong analytical, problem-solving, and critical thinking skills.
- Proficiency in Microsoft Office (Excel, PowerPoint, Word); MS Teams/Power BI/Power Automate preferred.
- Knowledge of cGMP regulations and FDA guidance related to cell-based product manufacturing.
- Solution-oriented mindset; ability to develop new procedures/alternate paths for improvement.
Benefits (as stated)
- Base pay range: $93,463–$122,670 (USD).
- Performance-based bonus and/or equity (eligible roles).
- Medical, dental, vision; 401(k) with company match (vests day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off: vacation, personal time, sick time, floating holidays, and 11 company holidays.
- Additional voluntary benefits: flexible spending/HSA, life & AD&D, short-/long-term disability, legal assistance, supplemental plans (pet, critical illness, accident, hospital indemnity), commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.