Global Biologics Analytical LCM Lead

Takeda; Brooklyn Park (MN); Vor Ort; USD 212.000 - 333.000; Vollzeit

Zusammenfassung

Takeda in Lexington, MA is seeking a seasoned Biologics Analytical LCM Leader to own the global analytical lifecycle management portfolio for biologics. You will manage program leads, shape control strategies, and align with QA, QC, Regulatory, and IT to ensure robust, compliant analytics across development and lifecycle stages.

The role requires 12+ years in pharma/biotech with deep expertise in analytical development, AQbD, and regulatory submissions.

Qualifikationen

• BS/MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences (PhD preferred).
• 12+ years in pharma/biotech with depth in Analytical Development and/or QC.
• Experience leading multiple biologics analytical programs (development and/or lifecycle).
• Experience supporting regulatory submissions (IND/IMPD/BLA/MAA).

Aufgaben

• Own the global Analytical LCM Biologics Portfolio strategy and roadmaps.
• Lead program leads with clear accountability, schedules, and resources.
• Collaborate with QA, QC, Regulatory, IT to align plans and resourcing.
• Drive AQbD, risk thinking, and tech transfer across programs.
• Champion analytical innovation and platform modernization.

Kenntnisse

Analytical development

Leadership

Regulatory submissions

Communication

Ausbildung

BS/MS in Biochemistry/Biology/Biotechnology/Chems/Pharma Sci (PhD preferred)

Tools

CDS/LIMS/ELN

Jobbeschreibung

Takeda in Lexington, MA is seeking a seasoned Biologics Analytical LCM Leader to own the global analytical lifecycle management portfolio for biologics. You will manage program leads, shape control strategies, and align with QA, QC, Regulatory, and IT to ensure robust, compliant analytics across development and lifecycle stages.

The role requires 12+ years in pharma/biotech with deep expertise in analytical development, AQbD, and regulatory submissions.