Senior Scientist, Analytical Development (AD)
Company: Takeda
Location: Lexington
Posted on: January 1, 2026
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description Objective / Purpose:
We are seeking a highly motivated Senior Scientist to join the
Potency and Functional Characterization team within Analytical
Development. This role will focus on design, development, and
validation of cell-based and ligand-binding assays to support the
characterization, release, and stability testing of biologics. The
ideal candidate will have deep expertise in bioassay development
and strong analytical skills. The is a lab-based role, and the
selected candidate will collaborate effectively within
cross-functional teams, including colleagues from Research, Quality
Control, Process Development, Drug Product Development, and
Regulatory Affairs to drive alignment on potency strategy and
successful transfer to Quality Control environments. The successful
candidate will stay abreast of emerging technologies, industry
trends, and regulatory expectations. This role will actively drive
innovation by evaluating and implementing novel analytical
approaches, automation solutions, and digital tools to enhance
method performance, efficiency, and data trending. Expertise in the
generation and/or use of analytical cell lines with stable
expression of targets of interests and/or reporter constructs to
enable measurement of signal transduction is preferred.
Accountabilities: Develop and optimize cell-based functional assays
and ligand-binding assays for potency determination of protein
therapeutics. Define potency strategy and method design based on
clinically relevant mechanisms of action (MoA), targeted method
performance, and transferability. Apply deep knowledge of
regulatory guidelines (ICH, USP chapters) to ensure compliance in
bioassay development and validation. Independently resolve complex
technical challenges and implement innovative solutions. Provide
sole technical leadership within assigned programs and offer
guidance across other programs as needed. Serve as a technical
resource and mentor, training colleagues across multiple
technologies. Stay current with emerging technologies, industry
trends, and regulatory expectations related to potency methods for
biologics. Review, interpret, and communicate complex data clearly
to functional leadership and cross-functional teams. Lead
technology transfer activities internally and externally, building
and maintaining key vendor relationships. Develop project
strategies within Analytical Development and across functions,
guiding team members to successful execution. Author technical
reports, regulatory filing sections, and scientific publications as
appropriate. Effectively manage multiple programs and represent
Analytical Development on project teams Education & Competencies
(Technical and Behavioral): Bachelors degree with 10 yrs relevant
experience, Masters degree with 8 yrs relevant experience, Ph.D.
with 2 yr relevant experience Demonstrated expertise in the
development, validation, and lifecycle management of cell-based
potency assays, including experience with relevant techniques and
technologies. Robust understanding of regulatory guidance and
industry standards relevant to analytical CMC activities,
particularly in the development and validation of potency assays
Demonstrated ability to communicate complex data clearly and
concisely, with excellent scientific writing skills, strong
attention to detail, and a proven track record of effective
cross-functional collaboration. 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: $137,000.00 - $215,270.00 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-term incentives. 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, Brookline , Senior Scientist, Analytical Development (AD), Science, Research & Development , Lexington, Massachusetts