Senior MSAT Director, Synthetic Molecule API

Takeda Pharmaceutical Company Limited; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Boston, MA is seeking an Associate Director for MSAT Synthetic Molecule API to lead technical programs for commercial drug substance manufacturing. The role requires directing cross-functional teams, driving process improvements, and managing external CDMOs while ensuring compliance with cGMP and CMC regulations.

The position emphasizes lifecycle management, data-driven decision making, and collaboration across QA, QC, and regulatory groups to deliver

Qualifications

• MS in chemistry, chemical engineering, pharmaceutical engineering or related scientific discipline with 5–10 years of experience; PhD with 5+ years of experience in commercial pharmaceutical/chemical industry for synthetic drug substance.
• Direct management experience with external Contract Manufacturing Organizations (CDMOs).
• Strong working knowledge of cGMP manufacturing operations and drug substance manufacturing for small molecules.
• Working knowledge of CMC regulations, cGMP, and ICH guidance lines.
• Knowledge of DoE and QbD.
• Advanced Excel and MS Office; JMP or MATLAB preferred.
• Strong written and oral communication skills; ability to work in cross-functional teams.

Responsibilities

• Provide direct leadership for day-to-day technical activities for Takeda's synthetic commercial drug substance manufacturing, including troubleshooting, process changes and improvements.
• Lead PPQ/validation, LCM strategies, and cross-functional process design and optimization.
• Interface between MSAT Synthetic Molecule and CDMOs, QA, QC, CMC regulatory and supply chain groups on technical issues.
• Compile and analyze production data (IPC, release, DoE) to improve quality and ROI on projects.
• Present manufacturing data in multi-disciplinary meetings to improve efficiency.
• Lead Change Controls, investigations, and CAPAs with internal and external stakeholders.
• Supervise interns, contractors, and FTEs as appropriate.

Skills

Technical leadership

cGMP knowledge

Project management

DoE & QbD

JMP/MATLAB

Manufacturing tech transfer

Education

MS in chemistry or related field

PhD in chemistry/related field

Tools

JMP

MATLAB

Excel

Job description

Takeda Pharmaceutical Company Limited in Boston, MA is seeking an Associate Director for MSAT Synthetic Molecule API to lead technical programs for commercial drug substance manufacturing. The role requires directing cross-functional teams, driving process improvements, and managing external CDMOs while ensuring compliance with cGMP and CMC regulations.

The position emphasizes lifecycle management, data-driven decision making, and collaboration across QA, QC, and regulatory groups to deliver