Associate Director, Separation Sciences, Biologics Analytical Development

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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.

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 candidates 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.

This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

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 actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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