Senior MSAT Lead - Synthetic Molecule API Process Science

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

Job summary

Takeda Pharmaceutical Co. in Boston, MA seeks an Associate Director - MSAT Synthetic Molecule API to lead technical operations for commercial drug substance manufacturing.

You will oversee process design, scale-up, tech transfer and lifecycle management while coordinating with CDMOs and Takeda QA/QC/CMC teams. The role requires MS or PhD with 5–10 years in pharma, strong cGMP knowledge, DoE/QbD experience, and expertise in managing external manufacturing relationships to ensure patient safety

Qualifications

• MS/PhD with 5–10 years in commercial pharma/chemical industry for synthetic drug substance
• Direct management experience with external CDMOs
• Strong knowledge of cGMP manufacturing operations and small molecule drug substance

Responsibilities

• Provide direct leadership for day-to-day technical activities in synthetic commercial drug substance manufacturing
• Lead interface between MSAT Synthetic Molecule and external manufacturers and Takeda QA/QC/CMC
• Author and review dossier sections related to commercial manufacturing submissions

Skills

CDMO management

cGMP knowledge

DoE

QbD

Education

MS in chemistry/chemical engineering/pharma

PhD +5 years in pharma/chemistry

Tools

Excel

Job description

Takeda Pharmaceutical Co. in Boston, MA seeks an Associate Director - MSAT Synthetic Molecule API to lead technical operations for commercial drug substance manufacturing.

You will oversee process design, scale-up, tech transfer and lifecycle management while coordinating with CDMOs and Takeda QA/QC/CMC teams. The role requires MS or PhD with 5–10 years in pharma, strong cGMP knowledge, DoE/QbD experience, and expertise in managing external manufacturing relationships to ensure patient safety