MSAT Senior Lead - Synthetic Molecule API

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. in Boston, MA seeks an Associate Director to lead MSAT Synthetic Molecule API manufacturing, process design, scale-up, tech transfer and lifecycle management for commercial drug substances.

You will manage internal and external teams, coordinate with QA, CMC and supply chain to ensure patient safety and business needs. The ideal candidate holds an MS or PhD in chemistry or chemical engineering, 5–10 years in pharma, strong cGMP knowledge, DoE/QbD experience, and

Qualifications

• The candidate should hold an MS in chemistry, chemical engineering or related scientific discipline; PhD with 5+ years acceptable.
• Strong knowledge of cGMP and ICH guidelines; experience with small molecules and drug substance manufacturing.
• Proficiency with DoE, QbD, process qualification and life-cycle management.
• Experience with external CDMOs and cross-functional QA/CMC interfaces.

Responsibilities

• Provide leadership for day-to-day technical activities in external drug substance manufacturing.
• Guide PPQ/Validation activities and lifecycle management for Takeda products.
• Lead cross-functional discussions with QA, QC, CMC RA, and supply chain.
• Analyze production data (IPC, DoE) to improve quality and ROI.
• Develop and review SOPs, investigations and CAPA resolutions.

Skills

Technical leadership

Project management

Cross-functional teamwork

DoE & QbD

Education

MS in chemistry or chemical engineering

PhD with 5+ years in pharma

Tools

JMP

MATLAB

Excel

Job description

Takeda Pharmaceutical Co. in Boston, MA seeks an Associate Director to lead MSAT Synthetic Molecule API manufacturing, process design, scale-up, tech transfer and lifecycle management for commercial drug substances.

You will manage internal and external teams, coordinate with QA, CMC and supply chain to ensure patient safety and business needs. The ideal candidate holds an MS or PhD in chemistry or chemical engineering, 5–10 years in pharma, strong cGMP knowledge, DoE/QbD experience, and