Senior Scientist, Analytical Development - Cell Therapy

BioSpace; New Jersey; Presencial; USD 127 000 - 167 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Resumo da oferta

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) in Somerset, NJ to lead analytical method development and qualification for cell/gene therapies. You will mentor junior scientists, collaborate across QC, PD, and Manufacturing, and drive robust data integrity and regulatory-compliant documentation.

The role requires hands-on leadership, expertise in flow cytometry, immunoassays, and bioanalytical methods, with a focus on late-stage development and technology transfer to

Qualificações

• Advanced degree (PhD or Master) in immunology, cell biology, biomedical engineering, or equivalent. 5-8 years (PhD) or 8-10 years (Master) of experience in method development of gene-modified products in analytical development and/or QC in a biotech or pharmaceutical setting.
• Expertise in analytical method development and qualification is required (Vaccine, Biologics, Viral Vector, or CGT).
• Solid understanding of ICH guidelines and regulatory expectations for method development and qualification/validation.

Responsabilidades

• Develop, optimize, and execute analytical methods to support cell and gene therapy product releasing and characterization.
• Guide method development activities to support phase-appropriate analytical deliverables with emphasis on scientific rigor and data integrity.
• Drive tech transfer of assays between collaborators, AD, QC, and external partners.
• Identify and refine critical parameters and materials during assay prequalification; qualify materials including cell banks.
• Develop and qualify release assays for early-phase clinical programs under tight timelines.
• Author and review analytical documentation including methods, SOPs, protocols, and reports.

Conhecimentos

Analytical method development

Flow cytometry

Cell culture

Immunoassays

ICH guidelines

Data analysis

Scientific leadership

GxP

Documentation

Biotech/CGT

Analytical transfer/validation

Statistical software

Formação académica

PhD or Master in immunology/cell biology/biomedical engineering

Ferramentas

GraphPad Prism

PowerBI

JUMP

R

FlowJo

NovoExpress

CytoExpert

LabVantage

Excel

PowerPoint

Descrição da oferta de emprego

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) in Somerset, NJ to lead analytical method development and qualification for cell/gene therapies. You will mentor junior scientists, collaborate across QC, PD, and Manufacturing, and drive robust data integrity and regulatory-compliant documentation.

The role requires hands-on leadership, expertise in flow cytometry, immunoassays, and bioanalytical methods, with a focus on late-stage development and technology transfer to