Senior Scientist, Analytical (FFBA) - Cell Therapy

Legend Biotech, Inc.; 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

Eight weeks paid parental leave

Paid time off and holidays

Job summary

Legend Biotech, Inc. in Somerset, NJ seeks a Senior Scientist, Analytical Development to establish, develop, and qualify analytical assays for cell/gene therapies.

You will mentor junior staff, collaborate with QC/PD/manufacturing, and ensure compliance with GxP and regulatory expectations. You will lead method development for release and characterization assays, oversee tech transfer, write SOPs and reports, and present data to internal and external stakeholders in a fast-paced biopharma

Qualifications

• Advanced degree with 5–8 years (PhD) or 8–10 years (Master) in gene-modified product analytics.
• Expertise in analytical method development and qualification under ICH/regulatory expectations.
• Experience with late-stage comparability, transfer, and validation strategies.

Responsibilities

• Develop, optimize, and qualify analytical assays for cell/gene therapy products.
• Lead tech transfer to QC and external collaborators with rigorous data integrity.
• Author SOPs, protocols, and analytical reports for regulatory submissions.
• Mentor junior scientists and collaborate cross-functionally to meet timelines.
• Present data at internal/external forums and drive continuous improvement.

Skills

Analytical method development

GxP knowledge

Flow cytometry

Cell culture

Immunoassays

Data analysis

QA/QC collaboration

Documentation writing

Cross-functional collaboration

Ind/BlA preparation

Statistics (GraphPad Prism)

PowerBI

R

Education

PhD in immunology, cell biology, biomedical engineering

Master in immunology, cell biology, biomedical engineering

Tools

GraphPad Prism

PowerBI

JUMP

R

Job description

Legend Biotech, Inc. in Somerset, NJ seeks a Senior Scientist, Analytical Development to establish, develop, and qualify analytical assays for cell/gene therapies.

You will mentor junior staff, collaborate with QC/PD/manufacturing, and ensure compliance with GxP and regulatory expectations. You will lead method development for release and characterization assays, oversee tech transfer, write SOPs and reports, and present data to internal and external stakeholders in a fast-paced biopharma