Associate Director, Separation Sciences, Biologics Analytical Development

POSITION OBJECTIVES

• Report to the Head, Biologics Analytical Development & Quality Control.
• Lead the Separation Sciences team, providing scientific, technical, and people leadership for separation-based analytical methods supporting biologics development.
• Lead analytical development for biologics programs, including method development, qualification, validation, and internal/external transfer for release and stability testing.
• Apply AQbD and platform-based approaches to ensure method robustness for regulatory filings, commercialization, and lifecycle management.

• Establish scientific/technical strategy for HPLC/UPLC and capillary electrophoresis assays for biologics development, GMP release, and stability testing.
• Design/update separation analytical methods using AQbD and risk-based thinking to create robust, compliant assay control strategies.
• Set phase-appropriate system suitability and assay control strategies aligned with regulatory expectations and ICH guidelines.
• Develop/implement/monitor/improve analytical platform methods and associated control strategies for separation-based assays.
• Provide subject matter expertise for lifecycle management and late-stage biologics programs.
• Lead technology development for GMP separation assays and support adoption of new analytical approaches.
• Lead/coach/develop a team; set priorities, allocate resources, and ensure delivery across the biologics portfolio.
• Partner with Process Development, Quality, Regulatory, and external partners for program goals and health authority responses.
• Author/review analytical content for CMC documents and support global filings.

• PhD (7+ yrs), MS (13+ yrs), or BS (15+ yrs) in analytical development or related field.
• Experience in biologics analytical development (HPLC/UPLC, capillary electrophoresis).
• Experience leading method development/qualification/validation/transfer for GMP release and stability testing.
• Experience with monoclonal antibodies, bispecifics, antibody-drug conjugates, or other complex biologics.
• Knowledge of AQbD, risk assessment, and phase-appropriate control strategies; ICH/regulatory expectations.
• Experience supporting regulatory submissions and health authority questions.
• Experience with Empower and JMP; electronic lab systems.
• Advanced data analytics/digital tools/automation/AI approaches preferred.
• Ability to lead and develop people while balancing technical depth and cross-functional work.