About the position
The Director of Gene Editing Analytics and Strategy at Legend Biotech will play a pivotal role in the Technical Development team, focusing on the characterization of gene editing in cell therapy products. This position is crucial for establishing and obtaining regulatory approval for product release strategies. The successful candidate will be responsible for creating a relevant analytical toolbox and performing quality control (QC) transfer and qualification for methods that are promoted for release. The role requires a deep understanding of molecular methods, particularly sequencing-based techniques, to characterize gene-edited products, alongside familiarity with regulatory expectations. The Director will oversee assay design, execution, and data analysis, ensuring that all processes meet the highest standards of quality and integrity. In this role, the Director will direct and execute the establishment of analytical methods for various gene manipulation techniques, including overexpression, knockdowns, knockouts, and knockins. Working collaboratively with a cross-functional team that includes non-clinical and regulatory colleagues, the Director will characterize edited cells using a comprehensive analytical toolbox, aiming to develop a robust understanding of editing efficiency and potential unintended effects. The characterization data will be leveraged to create a risk-based approach to product release, promoting relevant assays to release methods. The Director will also be responsible for obtaining regulatory feedback on characterization data and the release approach, which is essential for generating confidence in Investigational New Drug (IND) submissions. Additionally, the Director will guide the establishment and authoring of standard operating procedures (SOPs) for established methods, direct the transfer of release methods to internal or external QC as appropriate, and provide feedback to product design teams regarding gene edit designs. The role involves participating in cross-functional project teams to advance products through clinical trials, staying current on advancements in assay development and gene perturbation technologies, and working with technology development partners to enhance sequencing-based technologies. The Director will drive projects to meet established timelines while maintaining the highest quality and data integrity standards, analyze data for trends, and present findings in departmental meetings. Furthermore, the Director will provide analytical support for manufacturing and QC root cause investigations, author and review technical documents, and mentor junior scientists in experimental design and data analysis.
Responsibilities
- Direct and execute the establishment of analytical methods for characterization of various gene manipulation methods including overexpression, knockdowns, knockouts and knockins
- 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 establishment 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 and 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
- Ensure 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
