Job Description
Description
Key Responsibilities:
Extractables &Leachables(E&L) Strategy & Execution
Design and executeextractables andleachables(E&L) studies to supportinjectable biologicaldrug products, container closure systems, and medical devices.
Develop and authorE&L protocols, reports, and risk assessments in alignment with regulatory expectations.
Evaluateleachable profiles across stability studies, identifying trends and potential risks.
Analytical Testing & Characterization
Conduct and/or oversee analytical testing using advanced instrumentation, including:
GC-MS, Headspaceand Direct Inject
LC-UV/MS, LC-MS/MS
High-ResolutionMass Spectrometry (HRMS)
ICP-MS (elemental impurities)
Identifyand characterizeunknown compounds using spectral libra...
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