CMC Consultant

A company is looking for a CMC Consultant to execute Chemistry, Manufacturing & Controls strategy and operations. Key Responsibilities Define and execute CMC development strategy to support clinical progression and trial readiness Interface with external stakeholders and manage external partners for drug substance and product development Partner with regulatory team to shape CMC strategy for IND submission and support FDA interactions 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 in biotech/pharmaceutical settings Expertise in formulation development, analytical method development/validation, and GMP manufacturing Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements Ability to operate independently in a fast-paced, dynamic startup environment