Senior Scientist, Analytical Development - Cell Therapy

BioSpace; New Jersey; Vor Ort; USD 127.000 - 167.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) retirement with company match

Paid parental leave

Paid time off and holidays

Commuter benefits

Zusammenfassung

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) to join the Technical Development team in Somerset, NJ. You will establish, develop, and qualify analytical assays such as flow cytometry, cell culture-based methods, and immunoassays to support the development and manufacturing of cell therapy products.

The role requires leading scientific initiatives, mentoring junior staff, and ensuring data integrity while collaborating with QC, PD and Manufacturing.

Qualifikationen

• 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 or QC in biotech/pharma.
• Deep understanding of ICH guidelines and regulatory expectations for method development/qualification/validation.
• Experience in analytical method development and validation in late-stage product development is preferred.
• Experience with lentiviral vector product releasing and characterization methods including multicolor flow cytometry, cell culture, potency assays, immunoassays, and titer assays.

Aufgaben

• Develop, optimize, and execute analytical methods to support release and characterization of cell and gene therapy products.
• Lead cross-functional collaborations with QC, PD, and Manufacturing to ensure seamless assay execution and transfer.
• Author and review analytical methods, SOPs, and validation documents.
• Perform pre-qualification, assay qualification, release testing and stability studies in a QC environment.
• Mentor junior staff and drive scientific decision-making across multidisciplinary project teams.

Kenntnisse

Method development

Flow cytometry

Cell culture

Data analysis

GxP compliance

Ausbildung

PhD in immunology/biomedical sciences

Master in biotech/engineering

Tools

Excel

PowerBI

GraphPad Prism

FlowJo

FCS Express

LabVantage

ELN

Jobbeschreibung

Legend Biotech is seeking a Senior Scientist, Analytical Development (FFBA) to join the Technical Development team in Somerset, NJ. You will establish, develop, and qualify analytical assays such as flow cytometry, cell culture-based methods, and immunoassays to support the development and manufacturing of cell therapy products.

The role requires leading scientific initiatives, mentoring junior staff, and ensuring data integrity while collaborating with QC, PD and Manufacturing.