Lead MSAT: Synthetic Molecule API Process Science

Takeda; Zürich; On-site; CHF 159,000 - 219,000; Full time

Job summary

Takeda in Zurich seeks an Associate Director, MSAT Synthetic Molecule Drug Substance to lead technical operations for global external manufacturing. You will oversee process design, scale-up, tech transfer, and lifecycle management for specialty small molecules; manage cross-functional teams and CDMOs to ensure product quality and patient safety.

The role requires strong cGMP, QbD and ICH knowledge, experience with DoE/PPQ, and leadership of strategic investigations, CAPAs, and data-driven

Qualifications

• MS in chemistry, chemical engineering, pharmaceutical engineering or related scientific discipline.
• 5-10 years of experience in commercial pharma/chemical industry for synthetic drug substance.
• Experience direct management with external CDMOs.
• Strong knowledge of cGMP, QbD and ICH guidelines.

Responsibilities

• Provide day-to-day technical leadership for synthetic drug substance manufacturing and process improvements.
• Coordinate with MSAT Synthetic Molecule and CDMOs on technical issues, QA/QC, and regulatory teams.
• Lead PPQ/Validation and Life-Cycle Management activities to ensure compliance and efficiency.
• Analyze production data (IPC, DoE, release) to improve quality and ROI.
• Prepare Module 3 dossiers and author SOPs for manufacturing processes.
• Manage Change Controls, investigations, and CAPAs across internal and external teams.

Skills

Cross-functional teamwork

Written communication

Oral communication

DoE and QbD knowledge

Statistical analysis (JMP)

cGMP manufacturing knowledge

ICH guidelines knowledge

ISO guidelines knowledge

DoE and QbD understanding

Cross-functional leadership

Education

MS in chemistry, chemical engineering, pharmaceutical engineering or related scientific discipline

PhD with 5+ years in commercial pharma/chemical industry (synthetic drug substance)

Experience managing external CDMOs

Tools

Excel

JMP

MATLAB

Job description

Takeda in Zurich seeks an Associate Director, MSAT Synthetic Molecule Drug Substance to lead technical operations for global external manufacturing. You will oversee process design, scale-up, tech transfer, and lifecycle management for specialty small molecules; manage cross-functional teams and CDMOs to ensure product quality and patient safety.

The role requires strong cGMP, QbD and ICH knowledge, experience with DoE/PPQ, and leadership of strategic investigations, CAPAs, and data-driven