Cell Therapy Analytical Development (CTAD) in Summit, NJ

100% onsite required

Min Bachelors degree required

Must Haves:

• Experience with PCR and/or flow cytometry and/or mammalian cell culture is required.
• Execute GLP analytical tests to support process characterization testing of the lentiviral vector and cell therapy drug product samples.

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 in 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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