Takeda · 22 hours ago
Senior Scientist, Analytical Development (AD)
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff
$137K/yr - $215K/yr
8+ years expTakeda is seeking a highly motivated Senior Scientist to join the Potency and Functional Characterization team within Analytical Development. This role focuses on the design, development, and validation of cell-based and ligand-binding assays to support biologics characterization, release, and stability testing.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-09
2026-01-08
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