Strategic Analytical LCM Portfolio Lead

Takeda; Zürich; Sur place; CHF 175 000 - 275 000; Plein temps

Résumé du poste

Takeda seeks a senior Analytical LCM lead to own portfolio strategy and governance across modalities, driving scientifically sound decisions and risk-managed lifecycle management. You will coordinate with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure robust, compliant submissions and readiness.

The role emphasizes cross-modality planning, roadmap standardization, and capability building across global teams, with a focus on improving throughput and product quality.

Qualifications

• 12+ years in pharma/biotech with depth in Analytical Development and/or QC.
• Experience leading strategy, governance, and delivery across multiple programs including NDA or BLA filings.
• Experience developing analytical control strategies and supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA).
• Strong understanding of ICH AQbD, validation/verification, robustness, and lifecycle management.

Responsabilités

• Define, maintain, and communicate the global Analytical LCM Portfolio Strategy, including CMC processes and roadmaps.
• Own standardized approach for portfolio analytical LCM strategies across modalities.
• Establish Analytical LCM Portfolio Standardization & Governance and ensure data integrity and documentation practices.
• Develop and maintain method development and validation/verification roadmaps and governance.
• Prioritize analytical portfolio needs across internal and external labs.
• Build organizational capability on method risk registers and monitor performance.
• Collaborate with QA, QC, Manufacturing, Regulatory CMC, Supply Chain, and IT for submission-ready sections and inspection readiness.
• Drive continuous improvement in throughput, compliance, and quality outcomes.

Connaissances

AQbD

validation & lifecycle

Regulatory submissions

Scientific leadership

Stakeholder management

CDS/LIMS/ELN

Cross-modality coordination

Formation

BS/MS in Chemistry, Pharmaceutical Sciences, or related discipline (PhD preferred)

Outils

CDS/LIMS/ELN

Description du poste

Takeda seeks a senior Analytical LCM lead to own portfolio strategy and governance across modalities, driving scientifically sound decisions and risk-managed lifecycle management. You will coordinate with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure robust, compliant submissions and readiness.

The role emphasizes cross-modality planning, roadmap standardization, and capability building across global teams, with a focus on improving throughput and product quality.