CMC Lead

Job Summary

A company is looking for a CMC Lead to oversee drug development and manufacturing operations.

Key Responsibilities

• Oversee drug substance and product development at CDMO, including formulation optimization and stability
• Manage analytical method development and ensure compliance with regulatory standards
• Lead the execution of CMC strategy to support regulatory submissions and engage with FDA on CMC components

Required Qualifications

• Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
• 10+ years of drug development experience with leadership in CMC strategy
• Expertise in formulation development, analytical method validation, and GMP manufacturing
• Strong knowledge of FDA regulations and global regulatory requirements
• Experience in scaling products from early clinical to commercial manufacturing