Recruiter's Glossary

Examples: Drug Discovery • Compound Library • Quality Assurance

CMC

Term from Pharmaceutical Research industry explained for recruiters

CMC stands for Chemistry, Manufacturing, and Controls, which is a crucial part of drug development and approval. It covers everything about how medicines are made, from the initial ingredients to the final product. Think of it as the recipe and quality control system for making medications. When someone works in CMC, they help ensure that drugs are made consistently, safely, and at the right quality level every time. This is important because health authorities like the FDA need detailed information about how drugs are made before they can approve them for use by patients.

Examples in Resumes

Led CMC documentation team for new drug application submission to FDA

Managed Chemistry, Manufacturing and Controls activities for Phase III clinical trial materials

Coordinated with contract manufacturers on CMC requirements for drug production

Typical job title: "CMC Specialists"

Also try searching for:

CMC Manager CMC Director CMC Regulatory Affairs Specialist Pharmaceutical Development Scientist Drug Product Development Scientist CMC Project Manager Technical Operations Manager

Where to Find CMC Specialists

Professional Organizations

Job Boards

Professional Networks

Example Interview Questions

Senior Level Questions

Q: How would you handle a CMC strategy for a complex biological drug?

Expected Answer: Should explain their experience managing multiple aspects of drug development, including working with various teams, handling regulatory requirements, and ensuring quality control throughout the manufacturing process.

Q: Describe your experience with regulatory agencies regarding CMC submissions.

Expected Answer: Should demonstrate knowledge of working with FDA and other regulatory bodies, preparing documentation, and responding to agency questions about manufacturing processes and controls.

Mid Level Questions

Q: What key elements do you look for when reviewing batch records?

Expected Answer: Should discuss checking for consistency in manufacturing processes, proper documentation, quality control tests, and any deviations from standard procedures.

Q: How do you ensure CMC documentation meets regulatory requirements?

Expected Answer: Should explain their understanding of regulatory guidelines, quality standards, and experience in preparing or reviewing technical documentation.

Junior Level Questions

Q: What is the purpose of CMC in drug development?

Expected Answer: Should explain basic understanding that CMC ensures consistent quality in drug manufacturing and is required for regulatory approval.

Q: What are the main components of CMC documentation?

Expected Answer: Should identify basic elements like raw material specifications, manufacturing process descriptions, and quality control testing procedures.