Job Description
Position Summary
The Associate Director / Principal Scientist of Analytical Development will be responsible for small molecule CMC projects in terms of the development of analytical methodology and characterization of drug substances and drug products. This individual will support all analytical activities in contract development and manufacturing organizations (CDMOs). All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
Essential Duties And Responsibilities Identify analytical science capabilities and tools to characterize and support the manufacturing process development and QC testing for new drug candidates. Responsible for developing and implementing analytical strategies for development stage projects to achieve optimal res...
The Associate Director / Principal Scientist of Analytical Development will be responsible for small molecule CMC projects in terms of the development of analytical methodology and characterization of drug substances and drug products. This individual will support all analytical activities in contract development and manufacturing organizations (CDMOs). All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
Essential Duties And Responsibilities
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