Avid Bioservices Inc (CDMO)

[freethemice]

I found this definition of CMC:
Chemistry, Manufacturing, and Controls (CMC) constitutes that part of pharmaceutical development
that deals with the nature of the drug substance and drug product, the manner in which both are made, and the
manner by which the manufacturing process is shown to be in control.

This job sounds like a position created to deal with problems like those in the second-line trial.

Identifies CMC issues that may increase regulatory risk, and proposes strategies to address such risks.
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Evaluate compliance-related GMP issues and participate in the development of action plans to correct deficiencies.
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Work with CROs to prepare, file and maintain international regulatory submissions.