Scientist II, Analytical Development, Gene Editing and Molecular Assays
Legend Biotech
June 28, 2026
On-site
Somerset, NJ
Clinical Research and Development
Role Overview:
Develop analytical methods and perform QC/in-process testing to support manufacture and characterization of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. Maintain lab notebook records and report results timely.
Key Responsibilities:
- Develop, optimize, and qualify molecular biology methods (e.g., VCN, gene editing proficiency, infectious/genomic titer, rapid mycoplasma, surrogate RCL, residual DNA).
- Support routine testing of final product (GMP), stability, and in-process.
- Review testing data (data packets, final lot file, COA).
- Verify/review data and GMP documentation for multiple methods/products.
- Cross-train on complex analytical methods/products; train others.
- Author/revise technical documents (test methods, SOPs, specifications, trend reports, sample plans).
- Maintain lab notebooks; manage equipment maintenance/calibration and inventories.
- Procure/qualify materials; collaborate on analytical control strategy.
- Make routine decisions for assay development planning/execution; higher-level approvals for major changes.
Requirements:
- BS/MS/PhD in Molecular Biology, Cell Biology, Biochemistry, or related.
- BS: 6–8 yrs; MS: 4–6 yrs; PhD: 1–3 yrs in assay development.
- Assay development and GMP QC testing experience (e.g., qPCR/dPCR/ddPCR, ELISA, cell culture/cell-based assays).
- Knowledge of Global Regulatory and cGMP requirements; strong communication; fast-paced, deadline-driven.
Preferred:
- LIMS/ELN/Veeva/GraphPad Prism/JMP; method qualification/validation and tech transfer (CAR-T, vaccine, antibody, AAV, other biologics). Mandarin preferred.
Benefits (per job post):
Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/holidays) and voluntary benefits (e.g., HSAs/FSA, life/AD&D, disability, legal assistance).
Develop analytical methods and perform QC/in-process testing to support manufacture and characterization of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. Maintain lab notebook records and report results timely.
Key Responsibilities:
- Develop, optimize, and qualify molecular biology methods (e.g., VCN, gene editing proficiency, infectious/genomic titer, rapid mycoplasma, surrogate RCL, residual DNA).
- Support routine testing of final product (GMP), stability, and in-process.
- Review testing data (data packets, final lot file, COA).
- Verify/review data and GMP documentation for multiple methods/products.
- Cross-train on complex analytical methods/products; train others.
- Author/revise technical documents (test methods, SOPs, specifications, trend reports, sample plans).
- Maintain lab notebooks; manage equipment maintenance/calibration and inventories.
- Procure/qualify materials; collaborate on analytical control strategy.
- Make routine decisions for assay development planning/execution; higher-level approvals for major changes.
Requirements:
- BS/MS/PhD in Molecular Biology, Cell Biology, Biochemistry, or related.
- BS: 6–8 yrs; MS: 4–6 yrs; PhD: 1–3 yrs in assay development.
- Assay development and GMP QC testing experience (e.g., qPCR/dPCR/ddPCR, ELISA, cell culture/cell-based assays).
- Knowledge of Global Regulatory and cGMP requirements; strong communication; fast-paced, deadline-driven.
Preferred:
- LIMS/ELN/Veeva/GraphPad Prism/JMP; method qualification/validation and tech transfer (CAR-T, vaccine, antibody, AAV, other biologics). Mandarin preferred.
Benefits (per job post):
Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/holidays) and voluntary benefits (e.g., HSAs/FSA, life/AD&D, disability, legal assistance).