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Senior Analyst, Analytical Development And Testing
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Full-time
- Reporting directly to the Analytical Development (AD) and Testing Lead, the Analytical Development (AD) and Testing Senior Analyst will support the management of the life cycle of analytical development for in-process, release and stability program testing of raw materials, plasmids, cell/bacterial banks, drug substance and drug products, in support of discovery, development, and manufacturing of iECURE’s product portfolio from the clinic through commercial launch.
- The Senior Analyst will be a seasoned professional who has supported, executed, and helped define analytical development and testing strategy associated with all phases of drug development, including the coordination and preparation of document packages for regulatory submissions.
- Provide strong scientific background in implementation of molecular biology assays, microbiological safety assays, compendial methods and have deep understanding of phase appropriate method verification, qualification, validation, sample and data analysis, GLP, GMP requirements, ICH and FDA guidance.
- Support clinical assay development and help manage the operations and execution of clinical assays at CROs.
- Participate in the preparation, assembly and filing of CMC regulatory submissions to support development stage and new product approvals, including interactions between the company and health authority representatives to facilitate submissions.
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