Posted:1 day ago|
Platform:
Work from Office
Full Time
Assist in development, validation, and transfer of analytical methods (e.g., LC-MS, GC-MS) for detecting nitrosamine impurities at trace levels (ppm to sub-ppb) in drug substances and products.
Assist in investigation root causes of nitrosamine formation and implement mitigation strategies aligned with ICH Q3A(R2) and Q3B(R2) for impurity control
Design and oversee E&L studies for container closure systems, including method development (GC/MS, LC/MS, ICP-MS) and safety assessments per ICH Q3D and EMA guidelines 1114.
Collaborate with toxicology teams to establish safety thresholds and prepare E&L summaries for regulatory filings (IND, NDA, MAA)
Conduct risk assessments for potential leachable in collaboration with manufacturing and suppliers.
Gowrie Healthcare
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