ADL- Technology Transfer Executive Ass Manager
2 weeks ago
We are seeking ahighly skilled person to join the team. The ideal candidate willprovide technical expertise and guidance throughout the transferprocess focusing on process optimization scaleup and validationwithin the Analytical Method Developmentlab.
KeyResponsibilities:
- Developand optimize analytical methods for the analysis of pharmaceuticalcompounds using various techniques such as HPLC GC LCMS etc.
- Leadmethod transfer activities from R&D to the AnalyticalDevelopment lab ensuring seamless integration and compliance withregulatory requirements.
- Collaboratewith crossfunctional teams including R&D Quality Controland Regulatory Affairs to ensure timely and successful methodtransfer.
- Conductscaleup studies to ensure methods are robust and suitable formanufacturingscale.
- Performmethod validation activities in accordance with regulatoryguidelines (ICH FDAetc.).
- Troubleshootanalytical methods and instrumentation issues as needed.
- Maintainaccurate documentation of all method development transfer andvalidation activities in compliance with regulatory standards.
- Staycurrent with industry trends best practices and regulatoryrequirements related to analytical methoddevelopment.
Requirements Min610 Years of experience in pharmacompany
knowledge of HPLC, GC,LC-MS
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