Senior MSAT Lead — Synthetic Molecule API

Takeda Pharmaceutical Co.; Ireland; On-site; EUR 100,000 - 138,000; Full time

Job summary

Takeda Pharmaceutical Co. in Bray, Ireland, is seeking an Associate Director in MSAT Synthetic Molecule API to lead technical activities for commercial drug substance manufacturing. You will oversee design, scale-up, tech transfer, validation, and lifecycle management while collaborating with QA, CMC regulatory, and supply chain teams.

The role requires an MS or PhD with extensive pharma experience, strong DoE/QbD knowledge, and proficiency in JMP/MATLAB; international travel may be required.

Qualifications

• The candidate should have an MS in chemistry, chemical engineering or a related field with 5–10 years in pharma.
• PhD holders with 5+ years in commercial pharma/chemical industry for drug substance are preferred.
• Direct experience with external CDMOs and QA/CMC knowledge is highly desirable.
• Working knowledge of cGMP, CMC regulations, ICH guidance, and regulatory practices.
• Experience with DoE and QbD; proficient in MS Office and data analysis tools like JMP/MATLAB.
• Strong written and verbal communication skills for cross-functional teams.

Responsibilities

• Provide technical leadership for global external manufacturing of drug substance.
• Lead process design, scale-up, technology transfer, and validation activities.
• Manage Lifecycle Management and CAPAs; supervise interns/contractors.
• Coordinate with QA, QC, CMC RA, and supply chain teams on projects.
• Prepare dossier sections (Module 3) and support regulatory submissions.

Skills

Project leadership

Cross-functional teamwork

cGMP knowledge

DoE and QbD

Analytical software

Advanced Excel

Education

MS in chemistry or chemical engineering

PhD with 5+ years experience

Tools

Excel

JMP

MATLAB

Job description

Takeda Pharmaceutical Co. in Bray, Ireland, is seeking an Associate Director in MSAT Synthetic Molecule API to lead technical activities for commercial drug substance manufacturing. You will oversee design, scale-up, tech transfer, validation, and lifecycle management while collaborating with QA, CMC regulatory, and supply chain teams.

The role requires an MS or PhD with extensive pharma experience, strong DoE/QbD knowledge, and proficiency in JMP/MATLAB; international travel may be required.