Senior Scientist, Analytical Transfer & Development

Takeda; Lexington (VA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda in Lexington, MA seeks a Senior Scientist for Analytical Development and Transfer to provide scientific leadership across analytical technology transfers in the CMC portfolio. You will govern transfer strategies, documentation, and validation plans, partnering with internal labs, manufacturing sites, and external partners to ensure site readiness and compliant methods.

You will mentor staff, drive risk-based validation, and support regulatory submissions while maintaining inspection

Qualifications

• Fully adept in GMP and GxP environments with inspection-readiness mindset.
• Advanced understanding of analytical method transfer, co-validation, and verification.
• Expert knowledge of risk-based validation and ICH guidance.
• Advanced proficiency in analytical techniques including HPLC.
• Strong writing and documentation skills for regulatory materials.
• Experience supporting regulatory submissions and inspection readiness.

Responsibilities

• Develop and execute analytical technology transfer strategies across multiple programs and milestones.
• Lead or influence complex transfer programs across internal and external partners.
• Govern transfer documentation, validation plans, and acceptance criteria.
• Manage analytical vendor and contract laboratory relationships and performance.
• Act as technical authority for complex analytical issues and investigations.
• Collaborate with QA, QC, Manufacturing, Regulatory, and Supply Chain to align priorities.

Skills

GMP/GxP experience

Analytical transfer

HPLC methods

Regulatory submissions

Quality systems

Cross-functional collaboration

Documentation/writing

Project leadership

Job description

Takeda in Lexington, MA seeks a Senior Scientist for Analytical Development and Transfer to provide scientific leadership across analytical technology transfers in the CMC portfolio. You will govern transfer strategies, documentation, and validation plans, partnering with internal labs, manufacturing sites, and external partners to ensure site readiness and compliant methods.

You will mentor staff, drive risk-based validation, and support regulatory submissions while maintaining inspection