Job Description
Responsibilities
Include but are not limited to the following:
• Define and implement analytical strategies for new product development and lifecyle management.
• Serve as a senior technical leader and subject matter expert for analytical technologies.
• Lead cross-functional initiatives to optimize analytical processes and ensure regulatory compliance.
• Perform analytical method development and technology transfer including method verification and method validation to support product development and regulatory applications
• Read and interpret analytical methodology and USP monographs.
• Provide analytical data packages for regulatory filings (FDA, EMA)
• Operate UPLC/HPLC/GC as well as other analytical instruments and perform troubleshooting and calibration as needed.
• Perform analytical testing of pharmaceutical drug products and/or raw materials following analytical methodology while adhering to internal and external customer ...
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