Global Analytical LCM Portfolio Lead

Takeda; Linz; Presencial; EUR 189 000 - 296 000; Tempo integral

Resumo da oferta

Takeda seeks an senior analytical leader to own and drive the Analytical LCM Portfolio across modalities, ensuring standardized governance, risk management, and lifecycle oversight. You will align strategy with QA, regulatory, and manufacturing partners to accelerate technology transfer and ensure data integrity.

The role entails strategic leadership, resource prioritization across internal and external labs, and a focus on AQbD, risk-based validation, and regulatory support for NDA/BLA filings.

Qualificações

• 12+ years in pharma/biotech with depth in Analytical Development and/or QC
• Experience developing analytical control strategies and regulatory submissions
• AQbD, validation & lifecycle management
• Leadership across multiple programs and NDA/BLA filings
• Oversight of analytical platforms and informatics in regulated environments

Responsabilidades

• Define, communicate and maintain global Analytical LCM Portfolio Strategy
• Standardize analytical LCM strategies across modalities and network
• Oversee Analytical LCM resourcing and prioritization
• Collaborate with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain and IT for submission-ready analytical sections
• Drive continuous improvement in throughput, compliance and quality

Conhecimentos

Analytical development

Regulatory submissions

AQbD

Risk-based validation

Stakeholder management

Formação académica

BS/MS in Chemistry/Pharmaceutical Sciences

Ferramentas

CDS

LIMS

ELN

Descrição da oferta de emprego

Takeda seeks an senior analytical leader to own and drive the Analytical LCM Portfolio across modalities, ensuring standardized governance, risk management, and lifecycle oversight. You will align strategy with QA, regulatory, and manufacturing partners to accelerate technology transfer and ensure data integrity.

The role entails strategic leadership, resource prioritization across internal and external labs, and a focus on AQbD, risk-based validation, and regulatory support for NDA/BLA filings.