Senior Director, Small Molecule CMC Strategy

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

Job summary

Takeda Pharmaceutical Co. seeks a Senior Director, Small Molecule CMC Advisor to lead analytical development strategy for our small molecule portfolio.

You will act as SME across cross-functional teams, guiding programs from early-stage to NDA/MAA, mentoring analytics leaders, and advising on initiatives to reduce costs while maintaining quality and compliance. Responsibilities include defining specifications and control strategies, authoring regulatory submissions, and coordinating with QA and

Qualifications

• Bachelor's, Master's, or PhD with extensive industry experience in CMC for small molecules.
• Proven track record mentoring analytical leaders and project managers.
• Strong business sense to identify bottlenecks and cut costs.
• Deep knowledge of cGMP, ICH, FDA/EMA expectations for small molecules.
• Experience in analytical development/validation and tech transfer.

Responsibilities

• Lead analytical development strategies for API and drug products.
• Mentor and grow analytical development leaders and scientists.
• Design initiatives to streamline workflows and reduce costs.
• Establish specifications and control strategies.
• Author and defend analytical CMC sections for global filings.
• Partner with QA on OOS investigations and CAPAs.
• Collaborate with cross-functional teams across the project lifecycle.

Skills

Leadership

Mentorship

Strategic thinking

Project management

Regulatory awareness

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Master's degree

PhD

Job description

Takeda Pharmaceutical Co. seeks a Senior Director, Small Molecule CMC Advisor to lead analytical development strategy for our small molecule portfolio.

You will act as SME across cross-functional teams, guiding programs from early-stage to NDA/MAA, mentoring analytics leaders, and advising on initiatives to reduce costs while maintaining quality and compliance. Responsibilities include defining specifications and control strategies, authoring regulatory submissions, and coordinating with QA and