Location: Somerset,NJ, USA
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 Director Gene Editing Analytics and Strategy as part of the Technical Development team based in Somerset, New Jersey.
Role Overview
The Director of Gene Editing Analytics and Strategy will work on a cross-functional team to characterize gene editing in cell therapy products as well as establish and obtain regulatory approval for product release strategies. This will include creating a relevant analytical toolbox as well as performing appropriate QC transfer and qualification for methods promoted for release. The successful candidate will have expertise in molecular methods including sequencing-based methods used to characterize gene edited products as well as familiarity with regulatory expectations. The individual will be responsible for assay design, execution and data analysis.
Key Responsibilities
* Direct and execute the establishment of analytical methods for characterization of various gene manipulation methods including overexpression, knockdowns, knockouts and knockins
* On a cross-functional team including non-clinical and regulatory colleagues, characterize edited cells using a comprehensive analytical toolbox to create a strong understanding of editing efficiency and the potential for unintended effects
* Leverage characterization data to create a risk-based approach to product release, promoting relevant assays to release methods
* Obtain regulatory feedback on characterization data and release approach to generate confidence in IND submissions
* Guide the establish and authoring of SOPs/procedures for established methods
* Direct the transfer of release methods to internal or external QC as appropriate
* Provide feedback to product design teams regarding the design of gene edits
* Guide the design and execution of method qualification
* Participate in cross-functional project teams to advance products towards and through clinical trials
* Stay current on the latest advancements in assay development and gene perturbation technologies and apply relevant knowledge to development projects
* Work with technology development partners to advance sequencing-based technologies
* Drive projects to meet established timelines while maintaining the highest quality and data integrity standards
* Analyze data for trends and recommendations for scientific staff. Present analyzed data within and across departmental meetings
* Provide analytical support for manufacturing and QC root cause investigations for OOS/OOE
* Author and / or review technical documents, protocols and / or reports
* Procure and qualify required materials to perform experiments or testing
* Mentor or guide junior scientists with experimental design, data analysis and troubleshooting
* Responsible for ensuring effective, accurate and timely communication of project information
Requirements
* PhD. in Molecular Biology, Genetics, Biochemistry, or a related field
* 10+ years of industry experience in a biotech or pharmaceutical setting
* Deep technical understanding of and hands-on experience with gene editing tools (e.g. CRISPR/Cas9, TALEN, ZFN, etc)
* Strong background in mammalian cell culture, molecular biology assays, including nucleic acid isolation, amplicon sequencing, qPCR, ddPCR, bulk and single-cell NGS
* A working ability with sequencing-related bioinformatics is a plus
* Prior experience in CAR-T or related cell therapy development
* Knowledge of T-cell biology and immunology is a plus
* Expertise in analytical method development and validation
* Knowledge of cGMP and ICH guidelines
* Detail-oriented with expertise in problem solving and solid decision-making abilities
* Excellent written, verbal, and collaboration skills are essential
* Patient focus is a must
* English and Mandarin are preferred
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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.