What Does a CMC Specialist Do?

A Chemistry, Manufacturing, and Controls (CMC) Specialist plays a crucial role in the pharmaceutical and biotechnology industries by ensuring that all aspects of the product development process related to chemistry, manufacturing, and controls meet regulatory standards and guidelines.

The primary function of a CMC Specialist is to oversee and guide the development, manufacturing, and testing processes of drugs or biologics to ensure product quality and compliance with regulatory requirements. This involves a detailed understanding of the chemical and physical properties of the drug substance, the formulation of the drug product, the manufacturing processes, and the packaging and labelling of the final product.

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