Associate CMC Process Data Analyst

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 Associate CMC Process Data Analyst as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This role functions to support and ensure data integrity for the electronic data management systems encompassing a broad range of data streams associated with CAR-T development and manufacture. The preferred candidate will have demonstrated experience in GMP manufacturing and data management (prior experience with CAR-T products preferred) with appropriate statistical analysis capabilities.

Key Responsibilities

• Work with paper and electronic systems MES, SAP, LIMS, Anaplan, eLN, etc. to aggregate and verify data for manufacturing performance tracking and trending. Responsible for development of routine reports with verified data.
• Participate in the design and maintenance of tools, workflows, systems, and policy to maintain data quality for the integration of data from multiple sources.
• Support investigations to provide manufacturing data for deviation investigation and support with data analysis and visualization as required.
• Provide support for Technical Operations group with data support including data analysis assistance and data integrity review of trend investigations, process improvement study reports, regulatory responses, and Continuing Process Validation.
• Support Manufacturing Dashboard activities including updating, maintaining and creation of new visualizations.
• Conduct impact assessments for process and batch record change controls to assess impact on data collection strategy and physical or coding impact on data management and visualization tools.
• Assist with activities for mapping data from data lake (consolidated data from MES, SAP, eLIMS, etc) for use in reporting and analysis.

Requirements

• A minimum of a Bachelor’s degree in biology, science, engineering, mathematics/computer science, or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 1-3 years of experience within a cGMP environment in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Strong statistical analysis capability.
• Ability to work with paper and electronic system for data compilation including MES, SAP, LIMS, etc.
• Technical CAR-T knowledge or Biotech process knowledge preferred.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote efficiency and accountability.
• Strong attention to detail and drive for quality work.
• Clear and succinct verbal and written communication skills.

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.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Matched 401K
• Flexible Spending Account
• Health Savings Account
• AD&D Insurance
• Short-Term Disability
• Long-Term Disability
• Paid Maternity Leave
• Paid Paternity Leave
• Pet Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Accident Insurance
• Legal Insurance
• Commuter Benefits
• Employee Assistance Program