Senior Director, Small Molecule CMC Strategy

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

Job summary

Takeda Pharmaceutical Co. in Boston, MA is seeking a Senior Director, Small Molecule CMC Advisor to lead analytical development strategies for API and drug products.

You will mentor teams, guide cross-functional programs from early-stage to regulatory submission, and optimize timelines and costs while maintaining quality and compliance. The role is hybrid in Boston with global regulatory responsibilities, IND/CTA and NDA/MAA support, and a strong emphasis on sponsor collaboration and technical

Qualifications

• Bachelor’s degree and 25+ years of relevant industry experience.
• Master’s degree with 21+ years of relevant industry experience.
• PhD with 15+ years of relevant industry experience.
• Leadership and mentorship proven track record.

Responsibilities

• Lead analytical development strategies for API and drug products.
• Mentor analytical development leaders and scientists.
• Design strategic initiatives to streamline analytical workflows and reduce costs.
• Establish drug substance and drug product specifications and control strategies.
• Author and defend analytical CMC sections for regulatory filings (IND/CTA, NDA/MAA).
• Partner with QA to manage OOS investigations, deviations and CAPAs.
• Collaborate cross-functionally with Process Chemistry, Formulation, Regulatory Affairs, Quality, and Supply Chain.

Skills

Analytical strategy

Leadership

Mentorship

Cost optimization

Regulatory submissions

Quality & investigations

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Job description

Takeda Pharmaceutical Co. in Boston, MA is seeking a Senior Director, Small Molecule CMC Advisor to lead analytical development strategies for API and drug products.

You will mentor teams, guide cross-functional programs from early-stage to regulatory submission, and optimize timelines and costs while maintaining quality and compliance. The role is hybrid in Boston with global regulatory responsibilities, IND/CTA and NDA/MAA support, and a strong emphasis on sponsor collaboration and technical