Senior Director, Small Molecule CMC Strategy (Hybrid)

Takeda Pharmaceutical Company Limited; Boston (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Boston seeks a Senior Director, Small Molecule CMC Advisor to lead the analytical development strategy for small molecules across the development continuum. You will serve as the analytical SME for cross-functional teams, guiding programs from early-stage candidate selection through BLA/NDA registration and mentoring analysts to drive excellence and timely delivery.

You will partner with Process Chemistry, Formulation, Regulatory Affairs, Quality, and

Qualifications

• Bachelor's degree with extensive industry experience.
• Master's or PhD with deep small molecule CMC background.
• Strong leadership and mentorship of analytical teams across programs.
• Solid understanding of cGMP, ICH guidelines and global health authority expectations.

Responsibilities

• Lead analytical development strategies for drug substances (API) and drug products.
• Mentor analytical development leaders and scientists across project teams.
• Design and drive strategic initiatives to accelerate timelines and reduce costs.
• Establish scientifically justified specifications and control strategies for CMC.
• Author and defend analytical CMC sections for IND/CTA and NDA/MAA filings.
• Collaborate with QA on OOS investigations, deviations, and CAPAs.

Skills

Analytical leadership

Cross-functional collaboration

Strategic leadership

Project management

Education

Bachelor's degree

Master's degree

PhD

Job description

Takeda Pharmaceutical Company Limited in Boston seeks a Senior Director, Small Molecule CMC Advisor to lead the analytical development strategy for small molecules across the development continuum. You will serve as the analytical SME for cross-functional teams, guiding programs from early-stage candidate selection through BLA/NDA registration and mentoring analysts to drive excellence and timely delivery.

You will partner with Process Chemistry, Formulation, Regulatory Affairs, Quality, and