Associate Director, Small Molecule Analytical Development

Biogen seeks an Associate Director to lead analytical development for small molecule programs from early clinical stages through commercialization. The role combines scientific expertise with people leadership, directing method development, validation, control strategies, and regulatory submissions while mentoring analytical scientists.

Responsibilities

• Lead analytical development from method development through validation, transfer, and lifecycle management for drug substance and product programs
• Develop phase-appropriate control strategies for identity, assay, impurities, degradation products, and other critical quality attributes
• Author and review analytical content for regulatory submissions including INDs, NDAs, MAAs, and responses to health authority questions
• Represent Analytical Development on cross-functional CMC teams, contributing to strategy, risk assessment, and decision-making
• Manage, mentor, and develop analytical scientists while overseeing contract research and manufacturing organization activities

Requirements

• Ph.D. in analytical, pharmaceutical, or related chemistry with 6+ years pharma/biotech experience, or equivalent combination of degree and experience
• Expertise in small molecule analytical development including chromatography, spectroscopy, method validation, impurity profiling, and specifications
• Knowledge of regulatory expectations, ICH guidance, GMP principles, and CMC submission standards
• Demonstrated leadership of analytical workstreams or cross-functional CMC teams in matrixed environments
• Experience managing and mentoring scientific staff
• Strong written and verbal communication skills for diverse technical and non-technical audiences