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Scientist, Quality Control, Biological Assays
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$84,000 - $118,667 a year
Full-time
- Ins med is seeking a Scientist I/II of QC with broad knowledge and expertise in cell-based potency assays, molecular biology assays, and chemical/biochemical assays as applied to AAV gene therapy products.
- The scientist will be involved in transfer of method from Analytical Development into QC. The scientist will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and characterization.
- The role will perform potency analysis on lot release and stability samples for clinical phase Insmed AAV Gene Therapy products.
- Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically SDS-PAGE, western blot, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell‑based potency assays.
- Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
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