Analytical Development Scientist II — Cell Therapy

BioNJ Inc.

New Jersey

On-site

USD 95,000 - 140,000

Full time

14 days+

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Job summary

Legend Biotech in Somerset, NJ is seeking a Scientist II, Analytical Development to join the Technical Development team. You will establish and qualify analytical methods including flow cytometry, cell-based potency, and immunoassays to support cell and gene therapy programs.

The role involves method development, execution for product characterization, release and stability testing, and authoring/reviewing documents. Collaboration with PD, QC and Manufacturing is essential.

Qualifications

Bachelor's degree with 7+ years, or Master's 5–7 years, or PhD 2–4 years, or post-doc.
Strong background in flow cytometry, cell culture, ELISA and cell-based assays.
Experience with compendial methods is preferred.
Knowledge of ICH guidelines and regulatory expectations for method qualification.

Responsibilities

Develop, optimize, and execute analytical methods for viral vector and CAR-T characterization.
Author and review methods, protocols, and reports.
Maintain reagent inventory and qualify materials for methods.
Transfer methods to QC and external collaborators; receive methods from others.
Maintain ALCOA+ compliant electronic records and audits.
Collaborate with PD, QC, and Manufacturing to ensure assay success.
Present scientific data at internal and external forums.
Balance multiple projects to meet timelines.