Drug CMC Lead

Responsibilities

• Oversee drug substance and product development at CDMOs, focusing on formulation optimization
• Set technical requirements for drug quality attributes and analytical performance
• Manage analytical method development and validation for regulatory compliance
• Lead comparability strategies for clinical and commercial production
• Act as the primary contact for managing CDMO relationships and negotiations
• Drive technology transfer and ensure compliance with GMP standards
• Engage with regulatory authorities on CMC strategy and submission processes

Qualifications

• Advanced degree preferred in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
• 10+ years of drug development experience in biotech/pharmaceutical settings
• Demonstrated leadership of CMC strategy, particularly in regulatory contexts
• Expertise in formulation development, analytical method development/validation, and GMP manufacturing
• Strong knowledge of FDA regulations and global regulatory requirements

Benefits

• Opportunity to shape drug development in an innovative startup
• Collaborative, mission-driven work culture emphasizing teamwork
• Growth prospects as the company expands through clinical pipelines