Job Description
**Job Description Summary**: The Analytical Chemistry team, part of Chemistry, Manufacturing and Controls (CMC) Development team within Pharmaceutical Diagnostics (PDx) R&D at GE HealthCare, is responsible for analytical characterization, method development, and supporting documentation for early-phase research and new product introductions (NPIs).
Extractables are chemical compounds that can be ‘extracted’ out from materials like container closure systems and manufacturing process components when they are exposed to harsh or exaggerated operational or storage conditions. Leachables are a subset of these extractables that actually migrate into the drug product under normal storage or use conditions. Because extractables and leachables (E&L) are usually present in very low concentrations compared to drug products and excipients, highly sensitive and specific analytical methods must be developed and validated to detect and quantify them accurately, facilitating an assessment of their ...
Extractables are chemical compounds that can be ‘extracted’ out from materials like container closure systems and manufacturing process components when they are exposed to harsh or exaggerated operational or storage conditions. Leachables are a subset of these extractables that actually migrate into the drug product under normal storage or use conditions. Because extractables and leachables (E&L) are usually present in very low concentrations compared to drug products and excipients, highly sensitive and specific analytical methods must be developed and validated to detect and quantify them accurately, facilitating an assessment of their ...
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