Senior Analytical LCM Lead - Synthetic Molecules

Takeda Pharmaceutical Co.; Lexington (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda Pharmaceutical Co. in Lexington, MA is seeking a senior analytical leader to drive the Synthetic Molecules LCM program portfolio from late development through commercial launch.

You will provide technical direction, risk-based decisions, and governance for multiple programs, coordinating with MSAT, PharmSci, QC, Regulatory, and IT to ensure robust control strategies. The role requires deep expertise in AQbD, method lifecycle management, and regulatory submissions, with a proven track

Qualifications

• BS/MS in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field; PhD preferred.
• 12+ years in pharma/biotech with leadership of multiple analytical programs.
• Experience developing analytical control strategies and regulatory submissions.
• Strong AQbD, risk-based validation, and lifecycle management understanding.
• Proficiency with regulated analytical platforms and informatics systems.

Responsibilities

• Own analytical LCM Synthetic Molecules portfolio strategies from late dev to commercial.
• Lead cross-functional teams with QA, QC, Regulatory, and IT to align plans and resources.
• Drive method development, qualification/validation, and lifecycle management with AQbD.
• Support regulatory submissions and provide scientific leadership across programs.

Skills

Scientific leadership

Stakeholder management

AQbD

Risk-based thinking

Communication

GxP/regulatory awareness

Project governance

Education

BS/MS in Chemistry/ Biochemistry / Pharmaceutical Sciences

Tools

CDS/LIMS/ELN

Job description

Takeda Pharmaceutical Co. in Lexington, MA is seeking a senior analytical leader to drive the Synthetic Molecules LCM program portfolio from late development through commercial launch.

You will provide technical direction, risk-based decisions, and governance for multiple programs, coordinating with MSAT, PharmSci, QC, Regulatory, and IT to ensure robust control strategies. The role requires deep expertise in AQbD, method lifecycle management, and regulatory submissions, with a proven track