Scientist I, Analytical Development
Legend Biotech
August 10, 2026
On-site
Somerset, NJ
Operations
Role Overview
Scientist I to join Functional, Flow Cytometry and BioAnalytics within Analytical Development (Somerset, NJ). Establish, develop, and qualify analytical methods (compendial methods, flow cytometry, cell-based potency, immunoassays) to support characterization, release, and stability testing for Legend’s cell and gene therapy pipeline. Author/review documents, maintain ELNs, and collaborate cross-functionally.
Key Responsibilities
- Develop, optimize, and execute analytical methods for viral vector/CAR-T characterization (titer, particle size, flow cytometry, cell-based potency).
- Author and review methods, protocols, and reports.
- Maintain reagent inventory and order materials.
- Generate and qualify critical analytical materials.
- Follow lab safety standards (PPE, BSL2 best practices).
- Support pre-qualification, assay qualification, product release, and product characterization in QC.
- Perform method technology transfer to/from QC and external collaborators.
- Maintain ALCOA+ contemporaneous ELN records (instrument maintenance, sample inventory); perform peer/data integrity reviews.
- Troubleshoot, continuously improve, present data internally/externally, manage multiple priorities.
Requirements
- BS with 5+ years, or MS with 3–5 years, or PhD with 0–2 years.
- Experience with flow cytometry, mammalian cell culture, ELISA, and cell-based assays.
- Preferred: compendial methods; document change management; SOP/procedure authoring.
- Preferred/Expected: lentiviral vector characterization (infectious titer, potency, transduction efficacy); ICH/regulatory method qualification knowledge; regulated assay qualification/release.
- Tools: Excel/Word/PowerPoint; GraphPad Prism; PowerBI/JUMP/R; CytoExpert/FCS Express/NovoExpress/FlowJo; ELN/LabVantage.
- Strong written/verbal English; Mandarin preferred.
Benefits (explicit)
- Medical/dental/vision; 401(k) with match; 8 weeks paid parental leave after 3 months; PTO incl. 11 holidays.
Scientist I to join Functional, Flow Cytometry and BioAnalytics within Analytical Development (Somerset, NJ). Establish, develop, and qualify analytical methods (compendial methods, flow cytometry, cell-based potency, immunoassays) to support characterization, release, and stability testing for Legend’s cell and gene therapy pipeline. Author/review documents, maintain ELNs, and collaborate cross-functionally.
Key Responsibilities
- Develop, optimize, and execute analytical methods for viral vector/CAR-T characterization (titer, particle size, flow cytometry, cell-based potency).
- Author and review methods, protocols, and reports.
- Maintain reagent inventory and order materials.
- Generate and qualify critical analytical materials.
- Follow lab safety standards (PPE, BSL2 best practices).
- Support pre-qualification, assay qualification, product release, and product characterization in QC.
- Perform method technology transfer to/from QC and external collaborators.
- Maintain ALCOA+ contemporaneous ELN records (instrument maintenance, sample inventory); perform peer/data integrity reviews.
- Troubleshoot, continuously improve, present data internally/externally, manage multiple priorities.
Requirements
- BS with 5+ years, or MS with 3–5 years, or PhD with 0–2 years.
- Experience with flow cytometry, mammalian cell culture, ELISA, and cell-based assays.
- Preferred: compendial methods; document change management; SOP/procedure authoring.
- Preferred/Expected: lentiviral vector characterization (infectious titer, potency, transduction efficacy); ICH/regulatory method qualification knowledge; regulated assay qualification/release.
- Tools: Excel/Word/PowerPoint; GraphPad Prism; PowerBI/JUMP/R; CytoExpert/FCS Express/NovoExpress/FlowJo; ELN/LabVantage.
- Strong written/verbal English; Mandarin preferred.
Benefits (explicit)
- Medical/dental/vision; 401(k) with match; 8 weeks paid parental leave after 3 months; PTO incl. 11 holidays.