Senior Analytical Scientist, Cell Therapy Innovation

HireLifeScience; New Jersey; On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

8 weeks paid parental leave

Paid time off and holidays

Job summary

Legend Biotech is seeking a Senior Scientist in Analytical Development (FFBA) for the Technical Development team in Somerset, NJ. The role centers on establishing, developing, and qualifying analytical assays to support cell and gene therapy products.

The candidate will lead method development for flow cytometry, cell culture, immunoassays, and bioanalytical assays, ensure transfer to QC, and mentor junior scientists in a fast-paced, regulatory environment.

Qualifications

• Advanced degree in immunology, cell biology, biomedical engineering, or equivalent.
• 5–10 years in method development for gene-modified products in analytical development/QC.
• Expertise in analytical method development/qualification (CGT, vaccines, biologics).

Responsibilities

• Develop, optimize, and qualify analytical methods for cell and gene therapy products.
• Lead tech transfer of assays to QC and external collaborators.
• Oversee pre-qualification, assay qualification, release testing, and stability testing.
• Collaborate with QC, PD and Manufacturing for troubleshooting and improvement.
• Present data and maintain quality documentation.

Skills

Analytical method development

Flow cytometry

Cell culture

Immunoassays

Data analysis

GxP

ICH guidelines

Leadership/mentoring

English communication

AI literacy

Education

PhD in immunology or cell biology or biomedical engineering

Master in related field

Tools

Excel

PowerPoint

GraphPad Prism

PowerBI

JMP

R

CytoExpress/FlowJo

ELN/LabVantage

Job description

Legend Biotech is seeking a Senior Scientist in Analytical Development (FFBA) for the Technical Development team in Somerset, NJ. The role centers on establishing, developing, and qualifying analytical assays to support cell and gene therapy products.

The candidate will lead method development for flow cytometry, cell culture, immunoassays, and bioanalytical assays, ensure transfer to QC, and mentor junior scientists in a fast-paced, regulatory environment.