Associate Director, Separation Sciences, Biologics Analytical Development

3316 Takeda Development Center Americas•Lexington, MA

7d•Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Separation Sciences, Biologics Analytical Development in our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

Requirements

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.
Ability to lead and develop people while balancing technical depth, project priorities, and cross-functional work.

Nice To Haves

Experience leveraging advanced data analytics, digital tools, automation, or AI-enabled approaches to support analytical development and decision-making is preferred.

Responsibilities

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.
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.