The Director of Analytical Method Lifecycle Management will be responsible for working with a cross-functional team across multiple companies to set and execute a strategy to improve cell therapy analytical method speed, labor efficiency, cost, and quality in a commercial environment to ultimately improve patient drug access. These outcomes will be achieved by the successful candidate via employment of both technologies and best practices. The strategy will balance tradeoffs of timing, risk, and...
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 a Director, Analytical Lifecycle Management as part of the Technical Development team based out of our Raritan, NJ.
Role Overview
The Director of Analytical Method Lifecycle Management will be responsible for working with a cross-functional team across multiple companies to set and execute a strategy to improve cell therapy analytical method speed, labor efficiency, cost, and quality in a commercial environment to ultimately improve patient drug access. These outcomes will be achieved by the successful candidate via employment of both technologies and best practices. The strategy will balance tradeoffs of timing, risk, and cost as well as include a plan for updating validation and regulatory filings.
Key Responsibilities
- Attain familiarity with currently used cell therapy methods, their labor, time, and challenges
- Prioritize gaps based on impact, time and improvement cost, and risk associated with changes
- Identify approaches to improve method turnaround time, labor efficiency, cost, and quality
- Prepare a business case that describes investment, returns, and timing in the context of alternatives to direct consensus on the strategy
- Address necessary implementation needs including procedure generation, equipment qualification, assay validation updates, and regulatory filings
- Propose an integrated strategy including timelines and cost for developing and implementing method updates. Align strategy with planned changes in the cell manufacturing proccess
- Work closely with equipment partners to smoothly deliver technology with focus on the best interests of patients
- Maintain transparency, trust, collaboration, and patient-focus in a cross-functional, multi-company team
Requirements
- BS/MS/Ph.D. (or relevant experience) in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
- Broad expertise in key analytical methods such as flow cytometry, PCR, potency, microbiology methods
- Strong technical acumen
- Experience with cell therapies
- Ability to assemble a comprehensive business case clearly balancing the costs and returns of the project
- Familiarity with equipment and automation platforms
- Ability to harness technologies to address gaps
- Experience working in a commercial environment
- Ability to balance tradeoffs
- Knowledge of assay validation, updates, and regulatory filings in a commercial setting
- Excellent collaboration 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.