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 an Senior Scientist, Statistician CMO MSAT as part of the Global Manufacturing and Supply team based in Raritan, NJ.
Role Overview
The Data Management and Analysis position will be part of the CMO MSAT team supporting commercial manufacture of Carvykti at our external manufacture partners. He/she is part of an integrated virtual management team, working with our partner JNJ, to oversee the technical side of the CMO operation.
Key Responsibilities
- Collect, analyze critical process parameters (CPP) data, in-process testing data, and drug product release data to identify out-of-trend performance.
- Assist investigation and root cause analysis by performing data trending and statistical analysis.
- Represent CMO MSAT team in global MSAT forum.
- Work closely with internal site MSAT team to compare the site performance and identify opportunities to improve process and operation.
- Work with CMO on continuous process validation (CPV).
- Provide timely and accurate update on the CMO performance to manager and cross functional stakeholders.
Requirements
- BS/MS is required, Ph. D is preferred, in related technical disciplines: math, engineering, statistics, data science etc.
- Minimum 5 years for BS/MS, 3 years for PhD of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture experience is highly desirable.
- Proficient in mainstream data analysis software, such as Tableau, JMP is required.
- Experience working with CMO is a preferred.
- Results driven with strong analytical, problem solving and critical thinking skills.
- Experience in a fast-paced and dynamic environment.
- Excellent time-management and communication skills.
#Li-Onsite
#Li-JK2
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.
