Senior Director of Biologics

Job Summary

A company is looking for a Senior Director, Biologics to lead Chemistry, Manufacturing, and Controls activities for biologic product development.

Key Responsibilities

• Develop and execute CMC strategies for biologic products, ensuring regulatory compliance
• Build and lead a high-performing CMC team while fostering a culture of innovation
• Collaborate with internal and external partners to ensure seamless execution of CMC plans

Required Qualifications

• 10+ years of experience in the biopharmaceutical industry, specifically in CMC development for biologics
• MS or Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related field
• In-depth knowledge of biologics manufacturing processes and regulatory requirements
• Experience authoring and reviewing regulatory documents such as INDs and BLAs
• Proven ability to lead cross-functional teams and manage complex projects