Director – Gene Editing Analytics and Strategy
| Company | Legend Biotech |
|---|---|
| Location | Somerset County, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | PhD |
| Experience Level | Expert or higher |
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
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
Preferred Qualifications
- 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
- English and Mandarin are preferred