Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays
Legend Biotech
June 27, 2026
On-site
Somerset, NJ
Operations
Role Overview
Scientist II, Analytical Development (Flow Cytometry and Functional Assays) supporting establishment, development, and qualification of flow cytometry-based methods and cell-based potency assays for release, characterization, and stability assessment of cell therapy products.
Key Responsibilities
- Develop and optimize assays (potency/cell-based), flow cytometry, and bioanalytical assays (e.g., ELISA).
- Develop and qualify methods for LVV characterization (infectious titer assays, vector potency assays, vector-specific flow cytometry panels).
- Tech transfer to QC; execute methods in QC, perform assay prequalification/qualification, refine critical parameters/reagents, and generate critical materials (e.g., cell banks).
- Create SOPs and laboratory protocols for product release testing/characterization.
- Collaborate with PD, QC, and Manufacturing for assay execution, troubleshooting, and continuous improvement.
- Present data; maintain documentation (ELN, development plans/reports, equipment logs) and support inventory maintenance.
- Manage multiple projects to meet timelines while maintaining data integrity; prioritize weekly work and plan/execute assay development runs (with higher-level approvals for major changes).
Requirements
- PhD or Master’s (scientific discipline or engineering) + 2–5 years (postdoc allowed).
- Expertise in analytical method development and qualification/validation.
- Experience: multicolor flow cytometry, cell culture (reporter gene cell line development), potency/cytotoxicity/cytokine release assays, immunoassays, infectious titer assays.
- Experience developing LVV residual impurities assays.
- Solid ICH/regulatory understanding for method qualification; author/guide SOPs.
- Tools: Excel/Word/PowerPoint; GraphPad Prism; PowerBI/JUMP; CytoExpert/FCS Express/NovoExpress/FlowJo; ELN/LabVantage.
- English preferred; Mandarin a plus.
Benefits (explicit)
- Medical/dental/vision; 401(k) match; 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) + 11 company holidays; other voluntary benefits incl. flexible spending/HSAs, life/AD&D, disability, legal assistance, and supplemental insurance.
Scientist II, Analytical Development (Flow Cytometry and Functional Assays) supporting establishment, development, and qualification of flow cytometry-based methods and cell-based potency assays for release, characterization, and stability assessment of cell therapy products.
Key Responsibilities
- Develop and optimize assays (potency/cell-based), flow cytometry, and bioanalytical assays (e.g., ELISA).
- Develop and qualify methods for LVV characterization (infectious titer assays, vector potency assays, vector-specific flow cytometry panels).
- Tech transfer to QC; execute methods in QC, perform assay prequalification/qualification, refine critical parameters/reagents, and generate critical materials (e.g., cell banks).
- Create SOPs and laboratory protocols for product release testing/characterization.
- Collaborate with PD, QC, and Manufacturing for assay execution, troubleshooting, and continuous improvement.
- Present data; maintain documentation (ELN, development plans/reports, equipment logs) and support inventory maintenance.
- Manage multiple projects to meet timelines while maintaining data integrity; prioritize weekly work and plan/execute assay development runs (with higher-level approvals for major changes).
Requirements
- PhD or Master’s (scientific discipline or engineering) + 2–5 years (postdoc allowed).
- Expertise in analytical method development and qualification/validation.
- Experience: multicolor flow cytometry, cell culture (reporter gene cell line development), potency/cytotoxicity/cytokine release assays, immunoassays, infectious titer assays.
- Experience developing LVV residual impurities assays.
- Solid ICH/regulatory understanding for method qualification; author/guide SOPs.
- Tools: Excel/Word/PowerPoint; GraphPad Prism; PowerBI/JUMP; CytoExpert/FCS Express/NovoExpress/FlowJo; ELN/LabVantage.
- English preferred; Mandarin a plus.
Benefits (explicit)
- Medical/dental/vision; 401(k) match; 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) + 11 company holidays; other voluntary benefits incl. flexible spending/HSAs, life/AD&D, disability, legal assistance, and supplemental insurance.