CMC Consultant

Job Summary

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