Senior Scientist, Analytical Development (AD)

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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.