Senior MSAT Lead – Synthetic Molecule API

USA - 3345 Takeda Manufacturing U.S.A., Inc; Bray; On-site; EUR 100,000 - 138,000; Full time

Job summary

Takeda seeks an Associate Director for MSAT Synthetic Molecule API in Bray, Ireland. You will lead day-to-day technical activities, drive process improvements, and manage cross-functional interfaces with QA/QC, CMC regulatory, and supply chain teams.

Experience in phase-appropriate CMC development and PPQ/Validation, plus strong DoE and QbD knowledge, is essential. Expect international travel and cross-site collaboration in a global pharma environment.

Qualifications

• MS in chemistry, chemical engineering, pharmaceutical engineering or other scientific discipline with 5–10 years of experience, or PhD with 5+ years in commercial pharma/chemical industry for synthetic drug substances.
• Direct management experience with external CMOs preferred.
• Good working knowledge of cGMP manufacturing operations and drug substance manufacturing for small molecules.

Responsibilities

• Provide direct leadership for day-to-day technical activities in Takeda’s synthetic drug substance manufacturing, including troubleshooting and process improvements.
• Lead interface between MSAT Synthetic Molecule and third-party manufacturers as well as QA/QC, CMC regulatory, compliance, and supply chain groups.
• Lead data compilation and analysis (IPC, release, DoE) to improve product quality and ROI across projects.
• Lead QbD lifecycle management strategies and test processes to ensure robust manufacturing.
• Author SOPs and dossier sections (Module 3) for commercial manufacturing submissions.

Skills

Project leadership

CMC knowledge

DoE

QbD

Data analysis

Education

MS in chemistry or chemical engineering or pharmaceutical engineering or related

Tools

JMP

MATLAB

Job description

Takeda seeks an Associate Director for MSAT Synthetic Molecule API in Bray, Ireland. You will lead day-to-day technical activities, drive process improvements, and manage cross-functional interfaces with QA/QC, CMC regulatory, and supply chain teams.

Experience in phase-appropriate CMC development and PPQ/Validation, plus strong DoE and QbD knowledge, is essential. Expect international travel and cross-site collaboration in a global pharma environment.