Director of CMC, External Operations

📋 Description

• Lead outsourced CMC development partnerships to support clinical programs.
• Identify, qualify, and manage external CMOs/CDMOs in China.
• Oversee CMC outsourcing strategies, governance, and risk management.
• Ensure GMP clinical supply delivery and regulatory-compliant activities.
• Coordinate with QA, Regulatory Affairs, and cross-functional teams.
• Support regulatory submissions with CMC input and documentation.

🎯 Requirements

• PhD, MS, or equivalent in pharmaceutical sciences, chemistry, biology, or related field.
• Minimum 10 years in CMC development with external partner management.
• Strong knowledge of biologics, GMP, analytical development, and CMC regulatory needs.
• Experience with IND/CTA, regulatory filings, and cross-functional leadership.
• Excellent communication/negotiation skills; Mandarin and English preferred.

🎁 Benefits

• AbbVie-wide benefits package
• Opportunities for professional growth in a global pharma leader