Analytical Development Scientist - Cell Therapy
Key Responsibilities
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Develop, optimize, and validate analytical assays, including qPCR, RNAseq, flow cytometry, ELISA, and other cell-based functional assays to characterize cell therapy products
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Lead assay transfer activities between internal teams and external partners
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Design and execute experimental plans to meet project deliverables and timelines
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Author and review technical documents, including method development reports, SOPs, and CMC sections for regulatory filings
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Support regulatory submissions by generating and reviewing technical documentation
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Collaborate with cross-functional teams to support process development, product characterization, stability testing, and troubleshoot assay performance
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Apply Design of Experiment (DOE) approaches to establish robust, phase-appropriate analytical methods
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Provide scientific leadership and mentorship to junior scientists and foster a collaborative team culture
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Present data and insights at internal meetings and external conferences
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Stay updated on emerging analytical technologies to expand team capabilities
Minimum Qualifications
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Ph.D. in Cell Biology, Molecular Biology, Immunology, Biochemistry, Bioengineering, or a related field
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2+ years of post-doctoral experience in analytical development for cell and gene therapies
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Strong expertise in a broad application of molecular and cell-based assays, including RNAseq, flow cytometry, qPCR, and other molecular biology techniques
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Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative environment
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Demonstrated experience mentoring junior scientists or leading projects in a team setting
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Strong organizational skills and ability to work collaboratively across disciplines
Preferred Qualifications
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Hands-on experience in assay development, optimization, and validation in a GMP environment
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Experience in technology transfer processes between R&D and Quality Control or external partners
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Experience in authoring or reviewing CMC sections for IND/BLA submissions
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Familiarity with automation and high-throughput analytical platforms
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In-depth knowledge of regulatory requirements for cell therapy products, including FDA and EMA guidelines
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Knowledge of current trends and emerging technologies in cell therapy analytics