Associate Director, Separation Sciences, Biologics Analytical Development

Position Objectives

You will report to the Head, Biologics Analytical Development & Quality Control. Your responsibilities will include:

• 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 and external transfer for release and stability testing.
• Focus on separation-based technologies and apply AQbD and platform-based approaches to ensure method robustness to support regulatory filings, commercialization, and lifecycle management.

Position Accountabilities

• Lead the Separation Sciences group and establish scientific and technical strategy for HPLC/UPLC and capillary electrophoresis assays supporting biologics development, GMP release, and stability testing.
• Design and update analytical methods for separation, applying AQbD and risk-based thinking to build robust, compliant assay control strategies.
• Set phase-appropriate system suitability and assay control strategies in line with regulatory expectations and ICH guidelines.
• Develop, implement, monitor, and continuously improve analytical platform methods and associated control strategies for separation-based assays.
• Provide subject matter expertise and technical support for lifecycle management activities and late-stage biologics programs.
• Lead technology development for GMP separation assays and support the adoption of new analytical approaches.
• Lead, coach, and develop a team of scientists, setting priorities, allocating resources, building technical capabilities, and ensuring delivery across the biologics portfolio.
• Partner with Process Development, Quality, Regulatory, and external partners to support program goals, regulatory submissions, and responses to health authority questions.
• Author and review analytical content for CMC documents and support global filing activities in all major markets.
• Depending on the selected candidate's skills and experience, this role may also serve as the Analytical Team Lead for one or more biologics development programs, providing cross-functional analytical leadership.

Education, Behavioral Competencies and Skills

• PhD with 7+ years, MS with 13+ years, or BS with 15+ years of relevant experience in analytical development or a related discipline.
• Experience in analytical development for biologics, including HPLC/UPLC and capillary electrophoresis.
• Experience leading method development, qualification, validation, and transfer for release and stability testing in a GMP environment.
• Experience with monoclonal antibodies, bispecifics, antibody-drug conjugates, or other complex biologics.
• Knowledge of AQbD, risk assessment, and phase-appropriate control strategies.
• Understanding of regulatory expectations and ICH guidance for biologics.
• Experience supporting regulatory submissions and addressing questions from health authorities.
• Experience with electronic laboratory systems and data analysis tools such as Empower and JMP.
• Experience leveraging advanced data analytics, digital tools, automation, or AI-enabled approaches to support analytical development and decision-making is preferred.
• Ability to lead and develop people while balancing technical depth, project priorities, and cross-functional work.

Pay

U.S. Base Salary Range: $154,400.00 - $242,550.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Schedule

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Full time, Job Exempt: Yes.