Resham Narula, CMQOE

Manager, External Operations @ Legend Biotech

About

External manufacturing and CMO operations leader with 10+ years in regulated biotech, cell therapy, and CAR-T. I manage CMO networks, build governance frameworks, and drive operational performance across complex, high-stakes manufacturing programs across regulated manufacturing environments in biotech and cell therapy. I specialize in building structure where it doesn’t exist—establishing clear operating models, performance metrics, and execution discipline across cross-functional and external partner teams. My background spans external manufacturing, site PMO leadership, CMC program management, and validation/engineering, giving me a strong end-to-end view of how development, manufacturing, quality, and supply chain intersect. I’ve led portfolio management frameworks, manufacturing KPIs and dashboards, value stream mapping, and capacity expansion initiatives to improve delivery, efficiency, and compliance in fast-paced, high-stakes settings. I’m known for translating complex data into clear insights, influencing without authority, and driving sustainable improvements through structured problem-solving and continuous improvement principles. I thrive in roles that require both strategic thinking and hands-on execution, particularly in environments where operational rigor and adaptability are critical to success.

Country

United States

City

Austin

Industry

Pharmaceuticals

Skill

External Manufacturing, CMO management, Good Manufacturing Practice (GMP), car-t, Operational Excellence, Technical Project Leadership, KPI Dashboards, Risk Management, Project Management, Performance Management, Program Budgeting, Root Cause Problem Solving, Microsoft Power BI, Lean Principles, Continuous Integration (CI), Regulatory Audits, Change Control, Agile Project Management, KPI Implementation, Change Management

Experience

Manager, External Operations

Legend Biotech

2024-8 - Present · 2 yrs 2 mos

Raritan, New Jersey, United States

Own clinical and commercial manufacturing performance across an external CMO network for cell therapy products. Built and deployed manufacturing KPIs, dashboards, and operating governance to improve execution, visibility, and accountability. Lead end-to-end manufacturing operations, on-site assessments, issue resolution, and deviation management. Drive value stream mapping, capacity expansion, cost reduction, and operational improvement initiatives. Partner cross-functionally to track performance, risk, and efficiency gains. Proficiency in managing program budgets and constraints

Senior Project Manager

Legend Biotech

2023-2 - 2024-8 · 1 yr 7 mos

Raritan, New Jersey, United States

Designed and implemented a site-wide Project Portfolio Management (PPM) framework for a commercial CAR-T facility. Developed Power BI dashboards to enable capacity planning, prioritization, and data-driven decision-making. Managed manufacturing expansion, process optimization, and compliance programs. Delivered executive-level portfolio reporting and mentored project managers.

Technical Project Manager

Legend Biotech

2022-1 - 2023-2 · 1 yr 2 mos

Somerset, New Jersey, United States

Led cross-functional CMC and manufacturing readiness programs across early- and late-stage clinical assets. Served as interim program lead for three programs, owning timelines, risks, and regulatory coordination. Supported global submissions and health authority interactions through integrated planning and documentation readiness. Led technology transfer and CMO readiness for clinical manufacturing

Project Engineer

Novartis

2020-5 - 2022-1 · 1 yr 9 mos

East Hanover, New Jersey, United States

Executed qualification, validation, and CapEx projects supporting clinical manufacturing operations. Led IQ/OQ/PQ activities, risk assessments, and deviation management in a GxP environment. Managed vendors, project schedules, costs, and performance reporting

Senior Project Specialist

Novartis

2019-9 - 2020-4 · 8 mos

Morris Plains, New Jersey

*Promotion Led site-level process optimization and manufacturing improvement initiatives. Supported KPI tracking, portfolio reporting, and change control governance. Coordinated cross-functional teams and supported GMP audits and inspections.

Manufacturing Project Coordinator

Novartis

2018-7 - 2020-4 · 1 yr 10 mos

Greater New York City Area

Managed manufacturing change controls and process improvement projects using Agile PLM. Supported regulatory inspections and health authority commitments. Drove compliant execution of operational changes through structured planning and governance.

Systems Engineer

Infosys

2016-7 - 2017-8 · 1 yr 2 mos

Greater Chicago Area

• Supported and maintained critical applications for a leading energy client in Chicago, enhancing operational efficiency. • Developed an automated program using MS .NET for Bank Administration Files, streamlining data processing. • Coordinated between client and vendors to resolve technical issues and manage application updates effectively.

Medical Assistant

Carteret Comprehensive Medical

2012-3 - 2016-6 · 4 yrs 4 mos

Edison, NJ

Assist in arranging clinical assistance to patients, such as a physical therapy, recording information, entering medical records in systems, scheduling, verification, medical billing and inventory through participating healthcare provider.

Research Intern

Research Project- NJIT & University of Brideport

2012-6 - 2016-5 · 4 yrs

The project involves differentiation of Stem Cells into Cardiomyocytes on PCL+Graphene scaffolds, that includes deliverables: ♣ Electrospinning PCL, PCL+Graphene, and PVDF, PVDF+Graphene polymeric scaffolds ♣ Preparing and Maintaining a Cell Culture with fibroblasts and mouse embryonic stem cells ♣ Preparing Collagen gels ♣ Preparing a Western Blot ♣ Performing several basic biochemistry lab procedures