Associate Director, Separation Sciences, Biologics Analytical Development

Takeda; Lexington (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda in Lexington, MA seeks an Associate Director for Separation Sciences in Biologics Analytics Development. You will lead HPLC/UPLC and capillary electrophoresis methods for biologics, guide method development, validation, and tech transfer for release and stability testing.

You will partner with Process Development, Quality, Regulatory, and external teams to support regulatory submissions and lifecycle management, while mentoring a team of scientists and delivering robust analytical

Qualifications

• PhD with 7+ years, MS with 13+ years, or BS with 15+ years of relevant experience.
• 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, automation, or AI-enabled approaches to support analytical development and decision-making.

Responsibilities

• Lead the Separation Sciences group and establish scientific and technical strategy for HPLC/UPLC and capillary electrophoresis assays.
• Design and update analytical methods for separation, applying AQbD and risk-based thinking.
• 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.
• Provide subject matter expertise and technical support for lifecycle management activities.
• Lead technology development for GMP separation assays and support new analytical approaches.
• Lead, coach, and develop a team of scientists to deliver across the biologics portfolio.
• Partner with Process Development, Quality, Regulatory, and external partners to support program goals.
• Author and review analytical content for CMC documents and support global filing activities.
• Potentially serve as Analytical Team Lead for biologics programs.

Skills

HPLC/UPLC

Capillary electrophoresis

AQbD

Regulatory submissions

GMP experience

Leadership

Empower

JMP

Education

PhD in analytical development

MS in analytical/biologics

BS in related field

Tools

Empower

JMP

Job description

Job Description

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 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Empowering Our People to Shine

Discover more at takedajobs.com

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:

Lexington, MA

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.

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.