Global Biologics LCM Analytics Portfolio Lead

Takeda; Wien; On-site; EUR 189,000 - 297,000; Full time

Job summary

Takeda seeks a senior leader for Biologics Analytical LCM, responsible for strategy, roadmaps and governance across multiple biologics programs from late development through commercial. You will lead cross-functional teams, drive AQbD and risk-based thinking, and ensure robust analytical control strategies across a global network.

Youจะ will partner with QA, QC, Manufacturing, Regulatory CMC, and IT to enable submission-ready analytics and lifecycle management while advancing digital analytics

Qualifications

• 12+ years in pharma/biotech with Analytical Development and/or QC
• Experience leading multiple biologics analytical programs
• Proven record in regulatory submissions (IND/IMPD/BLA/MAA)

Responsibilities

• Single point of accountability for global Analytical LCM portfolio of Biologics
• Owns Analytical LCM Biologics Portfolio Strategy from late development through commercial
• Collaborates with MSAT, Pharm Sci, Quality, Regulatory, IT to align plans
• Drive analytical technology innovation and AQbD integration
• Maintain method risk registers and control strategies
• Coordinate with stakeholders to ensure lifecycle management across programs

Skills

Analytical Development

Program Leadership

Biologics

AQbD

Regulatory Submissions

Strategic Planning

Education

BS/MS in Biochemistry/related

Tools

LIMS

ELN

CDS

Job description

Takeda seeks a senior leader for Biologics Analytical LCM, responsible for strategy, roadmaps and governance across multiple biologics programs from late development through commercial. You will lead cross-functional teams, drive AQbD and risk-based thinking, and ensure robust analytical control strategies across a global network.

Youจะ will partner with QA, QC, Manufacturing, Regulatory CMC, and IT to enable submission-ready analytics and lifecycle management while advancing digital analytics