Senior MSAT Lead, Synthetic Molecule API

Takeda Pharmaceutical Co.

Zürich

On-site

CHF 159,000 - 219,000

Full time

2 days ago

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Job summary

Takeda Pharmaceutical Co. in Zurich is seeking an Associate Director for MSAT Synthetic Molecule Drug Substance to lead technical operations, process design, scale-up, technology transfer and lifecycle management of synthetic drug substances.

You will manage internal and external teams and ensure compliance with cGMP and ICH guidelines. The ideal candidate has an MS or PhD in a related field with 5–10 years of pharma experience, strong leadership, and hands-on experience with CDMOs, Process

Qualifications

MS or PhD in a scientific field with pharma/chemistry experience.
Direct management of external CDMOs and tech transfers.
Good working knowledge of CMC, cGMP and ICH guidelines.
Experience with DoE and QbD in lifecycle management.
Strong communication and cross-functional collaboration skills.

Responsibilities

Provide direct leadership for day-to-day technical activities in synthetic drug substance manufacturing.
Lead phase-appropriate CMC development, PPQ/Validation and LCM strategies.
Interface between MSAT Synthetic Molecule and external manufacturers and QA/QC/RA.
Analyze production data (IPC, DoE) to improve quality and ROI.
Author SOPs and manage Change Controls, investigations, and CAPAs.
Lead major technical projects for Takeda's synthetic molecule drug substances.