Skip to main content
Job Posting

Associate Director, Analytical Development – Biologics (Late Stage)

Lexington, Massachusetts
Apply Now
  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0155922 Date posted 06/30/2025 Location Lexington, Massachusetts

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’sPrivacy Noticeand 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.
Apply Now
Glassdoor Reviews and Company Rating
During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.

Alison Handley, Head, Center for External Innovation

The heart of our work

Shining a light on new perspectives

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Related Content

Jobs for you

View More Jobs
Exterior of Takeda Building

About our location

Lexington, Massachusetts


View Map of Lexington, Massachusetts