Manage CMC operations for drug products as a Director. Focus on late-phase development, commercial manufacturing, and regulatory compliance in a dynamic role.
This role centers on overseeing the late-stage development processes for small molecule drug products. You will manage the commercialization of these products through partnerships with CDMOs, providing regulatory oversight and ensuring quality compliance at every stage. Collaboration with various teams will be essential to drive product success in clinical trials and market entry.
Key Responsibilities:
• Direct late-phase process validation and scale-up operations
• Ensure compliance with industry regulations and standards
• Oversee preparation for commercial launch activities
• Manage audits and inspections with CDMOs
• Develop objectives aligned with overall company strategies
Requirements:
• PhD in relevant field with 10+ years of experience
• Extensive experience in drug manufacturing and commerc...