Associate Director, Analytical Development – Biologics (Late Stage)

Company: Takeda
Location: Lexington
Posted on: July 2, 2025

Job Description:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role At Takeda, we are guided by our purpose to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced analytical methods and drive the implementation of evolving scientific technologies to support late-stage biologics programs. With a deep focus on separation-based techniques (e.g., U/HPLC, CE-SDS, icIEF, glycan profiling, etc), you will lead a team to ensure analytical methods and strategies meet scientific, regulatory, and quality standards necessary for regulatory filings, commercial readiness, and lifecycle management.You will work within a collaborative, cross-functional Pharmaceutical Sciences team, contributing to program strategies and applying your expertise to ensure the delivery ofhigh quality innovative therapies to patients. How You Will Contribute Innovation & Talent Development Foster a culture of innovation, collaboration, and continuous improvement in Analytical Development. Drive publication strategies and engage with external scientific communities to share Takeda’s leadership in analytics. Build departmental capabilities, mentor staff, and ensure professional growth within the team. Leadership & Strategic Execution Independently lead and develop a team of analytical scientists, focusing on robust and phase-appropriate method development, validation, and transfer. Provide technical, managerial, and project leadership, aligning activities with Pharmaceutical Sciences’ and program objectives. Work with the leadership team to establish departmental vision and strategies. Technical Skills & Analytical Methodology Develop and implement high-quality analytical methods using separation-based techniques (U/HPLC, CE-SDS, icIEF, SEC, glycan profiling, etc). Apply Analytical Quality by Design (AQbD) principles, aligning with ICH Q14, ICH Q2(R2), and global regulatory expectations for biologics. Lead technical assessments and risk analyses to inform program strategies. Drive quality control and regulatory strategies for late-stage development, including BLA/MAA submissions and lifecycle management. Cross-Functional Collaboration & Regulatory Contributions Collaborate with Process Development, Regulatory, Quality, and external partners (CROs/CDMOs) to achieve CMC objectives and meet program timelines. Represent Analytical Development on cross-functional teams. Author and review CMC documents for regulatory submissions and address global health authority questions. What You Bring to Takeda Strong expertise in chromatographic and electrophoretic techniques (HPLC, CE-SDS, icIEF, etc) and biologics analytical control strategies. Solid knowledge of late-stage analytical development, including global regulatory requirements for Biologics (US, EU, Japan, China). Advanced experience with monoclonal antibodies, bispecifics, and/or ADCs. Knowledgeof electronic lab systems and software, such as Empower and JMP. Experience supporting regulatory filings and addressing agency questions. Demonstrated ability to review complex technical data, align strategies with program goals, and provide clear and concise communication to leadership. Education & Experience Ph.D. with 7 years, Master’s with 13 years, or Bachelor’s with 15 years of relevant experience in Analytical Development or a related discipline. What Takeda Offers At Takeda, we provide meaningful work in a collaborative environment and offer equitablecompensation and comprehensive benefits. Joining us means becoming part of a world-class organization that delivers Better Health and a Brighter Future to people worldwide. 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: $153,600.00 - $241,340.00 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. U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 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. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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.

Keywords: Takeda, Plymouth , Associate Director, Analytical Development – Biologics (Late Stage), Science, Research & Development , Lexington, Massachusetts