Cell Therapy Analytical Development; CTAD Job Summit area,New Jersey USA,Healthcare

Cell Therapy Analytical Development (CTAD)

100% onsite required

Summary:

Perform and interpret RT-qPCR/PCR, flow cytometry, cell-based potency, and other analytical assays with moderate supervision, as part of the Cell Therapy technical Operations (CTTO) team. Execute GLP analytical tests to support process characterization testing of the lentiviral vector and cell therapy drug product samples.

Responsibilities include, but are not limited to:

Perform experiments using the following methodologies: PCR, RT-qPCR, flow cytometry, mammalian cell culture, Luminex, MSD, and ELISA.

With moderate supervision design and execute analytical experiments of moderate complexity.

Perform data analysis, summarize and report experimental results.

Document/review laboratory work in notebooks that is detailed, accurate, timely, and in compliance with Good Lab Practices/Good Documentation Practices requirements.

Collaborate with the QC and Process Development teams to advance analytical and development projects.

Ensure proper operation and perform routine maintenance of all laboratory equipment.

Skills/Knowledge:

B.S. with 4+ years work experience or M.S. with 2+ years experience in Molecular & Cellular Biology, Immunology, or related discipline.

Experience with PCR and/or flow cytometry and/or mammalian cell culture is required.

Experience working in a regulated (GLP/GMP) environment is preferred.

Assay development, especially cell-based potency assays is preferred.

Assay qualification/validation experience is preferred.

Assay Technology Transfer (TT) experience is preferred.

Excellent organization skills and ability to handle multiple tasks.

Highly motivated, willingness to acquire new skills, and ability to work with minimal supervision.

Excellent verbal and written communication skills.

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