Biologics Analytical LCM Portfolio Lead

Takeda Pharmaceutical Company Limited; Lexington (MA); Sur place; USD 212 000 - 333 000; Plein temps

Résumé du poste

Takeda in Lexington, MA, seeks a senior leader to own the global Analytical LCM Biologics Portfolio, guiding strategy from late development through commercial. You will lead program roadmaps, align cross-functional teams, and ensure robust control strategies for biologics products across the lifecycle.

You will drive AQbD, risk-based method development, and regulatory submissions support, partnering with QA, QC, IT, and regulatory groups to deliver compliant, high-quality biologics programs at

Qualifications

• Education in a life sciences field is required with advanced degree preferred.
• 12+ years in pharma/biotech with leadership of multiple biologics analytical programs.
• Experience supporting regulatory submissions (IND/IMPD/BLA/MAA) and lifecycle management.

Responsabilités

• Own the global Analytical LCM Biologics Portfolio Strategy from late development to commercial.
• Provide deep technical and regulatory insights and lead cross-functional program plans.
• Collaborate with QA, QC, IT, Regulatory, and manufacturing to align control strategies.
• Drive AQbD, risk-based thinking, method development, and tech transfer across programs.
• Balance portfolio prioritization, resource planning, and readiness for filings.

Connaissances

Leadership

Communication

AQbD

Risk-based thinking

Method development

Regulatory filings

Platform modernization

Biologics analytics

Team management

Formation

BS/MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or related (PhD preferred)

Outils

CDS/LIMS/ELN

Description du poste

Takeda in Lexington, MA, seeks a senior leader to own the global Analytical LCM Biologics Portfolio, guiding strategy from late development through commercial. You will lead program roadmaps, align cross-functional teams, and ensure robust control strategies for biologics products across the lifecycle.

You will drive AQbD, risk-based method development, and regulatory submissions support, partnering with QA, QC, IT, and regulatory groups to deliver compliant, high-quality biologics programs at