Senior Director, Analytical Development

Job Summary

Providing strategic and operational leadership, the full-time Senior Director, Analytical Development will manage all analytical activities supporting drug substance and product development, ensuring regulatory compliance and delivering high-quality analytical data in a remote setting.

Key Responsibilities

• Define and execute the analytical development and QC strategy across all development stages
• Lead the development, qualification, validation, and transfer of analytical methods for drug substances and products
• Oversee compliance with cGMP and quality system requirements in internal and external QC testing labs

Required Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• 15+ years of experience in analytical development and/or QC within the biopharmaceutical or pharmaceutical industry
• 7+ years in leadership roles with experience in building and scaling teams
• Direct experience supporting late-stage development and commercial products
• Strong track record of regulatory interactions and successful submissions