CMC Lead
Virtual Vocations Inc, New York, NY, United States
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
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