Associate Director of Analytical Sciences

Job Summary

Overseeing structural and functional characterization and comparability studies, the full-time Associate Director of Analytical Sciences will provide strategic and operational leadership for analytical characterization and comparability in collaboration with internal teams and global CDMO partners.

Key Responsibilities

• Provide strategic and technical leadership for multidimensional biologics characterization to support regulatory submissions for clinical development
• Serve as a subject matter expert in mAb and mAb-mAb combination product molecular characterization and comparability, utilizing a suite of analytical methods
• Lead comparability and characterization activities at CDMOs, ensuring compliance with scientific and regulatory standards

Required Qualifications

• Advanced degree in a relevant discipline with 8+ years of biopharma industry experience in biologics analytical, formulation, or process development
• Demonstrated experience supporting regulatory submissions (IND, CTA, BLA) with expertise in characterization and comparability studies
• Proven leadership skills with the ability to manage biologics program deliverables in a fast-paced environment
• Experience with mAb combination products and device testing is preferred
• Familiarity with leveraging AI and ML to enhance analytical efficiency and support decision-making