MSAT API Lead - Synthetic Molecules, Global Manufacturing

Takeda; Bray; On-site; EUR 100,000 - 138,000; Full time

Job summary

Takeda is seeking an Associate Director for MSAT Synthetic Molecule API in Bray, Ireland. The role leads day-to-day technical activities for commercial drug substance manufacturing, coordinating with external CDMOs and Takeda QA/CMC teams to ensure robust process design and LCM execution.

You will drive PPQ/validation strategies, DoE/QbD activities, and data-driven improvements while mentoring staff and managing cross-functional programs across regions.

Qualifications

• MS in chemistry, chemical engineering, pharmaceutical engineering or related discipline.
• 5–10 years of experience in commercial pharmaceutical/chemical industry for synthetic drug substance.
• Direct experience with external Contract Manufacturing Organizations.
• Working knowledge of cGMP manufacturing operations and drug substance manufacturing with small molecules.
• Knowledge of CMC regulations, cGMP and ICH guidance.
• Experience with DoE and QbD concepts.
• Advanced Excel and familiarity with JMP or MATLAB.

Responsibilities

• Provide direct leadership for day-to-day technical activities for Takeda’s synthetic commercial drug substance manufacturing.
• Lead interface between MSAT Synthetic Molecule and third-party drug substance manufacturers and with QA/CMC/regulatory/supply chain groups.
• Lead data compilation and analysis of production data (IPC, release, DoE, manufacturing process information).
• Author and review SOPs and manufacturing process instructions.
• Direct and provide technical leadership on Change Controls, investigations, and CAPAs.
• Lead key technical projects relating to manufacturing of Takeda commercial MSAT NL drug substance.

Skills

External CDMO management

cGMP knowledge

CMC regulations knowledge

DoE

QbD knowledge

Excel advanced

JMP

MATLAB

Cross-functional leadership

Statistical analysis

Education

MS in chemistry or chemical engineering

PhD with 5+ years in industry

Tools

JMP

MATLAB

Job description

Takeda is seeking an Associate Director for MSAT Synthetic Molecule API in Bray, Ireland. The role leads day-to-day technical activities for commercial drug substance manufacturing, coordinating with external CDMOs and Takeda QA/CMC teams to ensure robust process design and LCM execution.

You will drive PPQ/validation strategies, DoE/QbD activities, and data-driven improvements while mentoring staff and managing cross-functional programs across regions.