Associate Director, MSAT - Synthetic Molecule API

Takeda Pharmaceutical Co.; Glattbrugg; Vor Ort; CHF 159.000 - 219.000; Vollzeit

Zusammenfassung

Takeda is seeking an Associate Director, MSAT Synthetic Molecule API in Zürich to lead technical operations for commercial drug substance manufacturing. You will oversee process design, optimization, scale-up, tech transfer, and lifecycle management, coordinating internal and external teams and CDMOs to ensure product quality and supply continuity.

The role requires strong program management, cGMP knowledge, and experience with DoE/QbD, as well as the ability to present data to cross-functional

Qualifikationen

• MS/PhD with experience in commercial pharmaceutical/chemical industry for synthetic drug substances.
• Direct management experience with external CDMOs.
• Good working knowledge of cGMP manufacturing operations.
• Knowledge of CMC regulations, cGMP, and ICH guidance lines.
• Experience with DoE and QbD concepts.
• Strong communication skills to work across functions.

Aufgaben

• Lead day-to-day technical activities for Takeda’s synthetic commercial drug substance manufacturing.
• Interface between MSAT Synthetic Molecule and CDMOs and internal QA/QC, CMC regulatory teams.
• Lead data analysis (IPC, DoE, and production data) to improve quality and ROI.
• Author SOPs and process instructions; manage change controls and CAPAs.
• Mentor interns/contractors as needed.

Kenntnisse

cGMP manufacturing

DoE & QbD

JMP/MATLAB

Process qualification

Data analysis

Communication

Cross-functional collaboration

Excel

Ausbildung

MS in chemistry or chemical engineering or pharmaceutical engineering

PhD with 5+ years experience

Tools

MATLAB

JMP

Jobbeschreibung

Takeda is seeking an Associate Director, MSAT Synthetic Molecule API in Zürich to lead technical operations for commercial drug substance manufacturing. You will oversee process design, optimization, scale-up, tech transfer, and lifecycle management, coordinating internal and external teams and CDMOs to ensure product quality and supply continuity.

The role requires strong program management, cGMP knowledge, and experience with DoE/QbD, as well as the ability to present data to cross-functional