MSAT Strategy Lead — Synthetic Molecule API

Takeda; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda in Boston, MA is seeking an Associate Director, MSAT Synthetic Molecule API to provide technical leadership for the global external manufacturing of commercial drug substance. The role focuses on process design, optimization, scale-up, tech transfer, validation, and lifecycle management, coordinating with QA, QC, and regulatory teams.

You will lead internal and external staff on technical programs, manage CMC and DoE, implement QbD, and ensure compliance with ICH guidelines, cGMP, and ISO

Qualifications

• MS or PhD with pharma experience.
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Skills

cGMP knowledge

CMC regulations

DoE and QbD

External CDMOs management

Cross-functional leadership

Data analysis

Communication

Education

MS in chemistry or chemical engineering

PhD with 5+ years in pharma/chem industry

Tools

JMP

MATLAB

Excel

Job description

Takeda in Boston, MA is seeking an Associate Director, MSAT Synthetic Molecule API to provide technical leadership for the global external manufacturing of commercial drug substance. The role focuses on process design, optimization, scale-up, tech transfer, validation, and lifecycle management, coordinating with QA, QC, and regulatory teams.

You will lead internal and external staff on technical programs, manage CMC and DoE, implement QbD, and ensure compliance with ICH guidelines, cGMP, and ISO