Senior Scientist, Analytical Development — Cell Therapy

BioNJ Inc.; New Jersey; On-site; USD 130,000 - 180,000; Full time

Job summary

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) in Somerset, NJ. You will establish, develop and qualify analytical assays for CGT pipelines, including flow cytometry, immunoassays, and cell culture-based methods, with a hands-on leadership approach.

Responsibilities include tech transfer, data interpretation, and cross-functional collaboration to meet aggressive timelines and regulatory expectations in a GxP environment.

Qualifications

• Advanced degree required with 5–8 years (PhD) or 8–10 years (MS) in CGT analytical development.
• Expertise in analytical method development and validation for gene-modified products.
• Solid understanding of ICH guidelines and regulatory expectations.

Responsibilities

• Develop, optimize, and execute analytical methods for release and characterization of cell/gene therapy products.
• Lead tech transfer of assays to QC and external collaborators.
• Identify critical parameters and qualify materials including cell banks.
• Draft and review analytical methods, SOPs, protocols, and reports.
• Collaborate with QC, PD, and Manufacturing for seamless assay execution.
• Present data trends and maintain lab notebooks and QC records.

Skills

Analytical method development

Leadership

GxP compliance

Communication

Data interpretation

Education

PhD in Immunology or Cell Biology

MS in relevant field

Tools

Flow cytometry

HPLC

ELISA

Cell culture assays

Excel/GraphPad

Job description

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) in Somerset, NJ. You will establish, develop and qualify analytical assays for CGT pipelines, including flow cytometry, immunoassays, and cell culture-based methods, with a hands-on leadership approach.

Responsibilities include tech transfer, data interpretation, and cross-functional collaboration to meet aggressive timelines and regulatory expectations in a GxP environment.