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Position Overview:

We are seeking a Specialist/Sr. Specialist with experience in technical transfer, qualification, validation and GMP routine testing of functional and potency assays for lot release and stability of cell and gene therapy products. This contributor will be responsible for execution complex experiments in a GMP environment. The ideal candidate will be independent and detail oriented, previous experience in design and development of functional cell-based assays, work collaboratively with cross-functional teams, and have a working knowledge of ICH/USP guidelines and potency matrix/assurance strategies.

Primary Responsibilities:

• Optimize, technical transfer, qualification, and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
• Execution of complex GMP release and stability assays including cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
• Author and review SOPs and technical reports.
• Acting as an SME resource to external partners.
• Work with cross-functional groups including Research & Development, Analytical Development, and Process Development teams to participate in various aspects of method development, transfer, process and product characterization, comparability, and investigations.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.

Qualifications:

• Master’s degree with 10+ years of relevant experience or bachelor’s with 12+ years of experience.
• Strong background in cell culture and experience working with cell lines and primary human cells.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, flow cytometry, ELISA, and NGS.
• Experience using data analysis software including JMP and PLA software.
• Knowledge of ICH/USP guidelines.
• Proven track record of functional and potency assay technical transfer, qualification, and validation in a GMP laboratory.
• Ability to critically think though experimental challenges and troubleshoot.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented, and excellent problem-solving abilities.
• Domestic and international travel may be required to external CTLs and other Beam sites.