Biologics Separation Sciences Lead, Analytical Development

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); Hybrid; USD 154,000 - 243,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Takeda in Lexington, MA seeks an Associate Director to lead Separation Sciences for biologics analytical development, including method development, qualification, validation, and technology transfer for release and stability testing.

The role emphasizes AQbD, compliant strategies, and collaboration with Process Development, Quality, and Regulatory teams. Hybrid work arrangement available and strong leadership required.

Qualifications

• PhD/MS/BS with extensive experience in biologics analytical development and GMP.
• Experience in HPLC/UPLC and capillary electrophoresis for release and stability.
• Familiarity with AQbD, regulatory expectations, and ICH guidance.

Responsibilities

• Lead Separation Sciences for biologics analytical methods and transfer.
• Develop and validate separation-based assays for GMP release and stability.
• Guide technology development and cross-functional collaboration.

Education

PhD with 7+ years in analytical development or related discipline

MS with 13+ years

BS with 15+ years

Tools

HPLC/UPLC

Capillary electrophoresis

Empower

JMP

Job description

Takeda in Lexington, MA seeks an Associate Director to lead Separation Sciences for biologics analytical development, including method development, qualification, validation, and technology transfer for release and stability testing.

The role emphasizes AQbD, compliant strategies, and collaboration with Process Development, Quality, and Regulatory teams. Hybrid work arrangement available and strong leadership required.