Process Science Manager: Remote & Global Tech Transfer

Takeda Pharmaceutical Company Limited; Boston (MA); Hybrid; USD 140,000 - 182,000; Full time

Job summary

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will drive characterization, validation, and continuous improvement while coordinating cross-site activities and regulatory interactions. Qualified candidates hold an advanced degree with 8+ years of related experience, including design of development strategies, scale-up, and regulatory documentation.

Qualifications

• Advanced degree and 8+ years in formulation/process development or equivalent.
• Experience leading technology transfer, scale-up and process validation.
• Regulatory documentation support including CMC dossiers.

Responsibilities

• Lead major technical transfer or validation projects for new product introductions or lifecycle management.
• Provide SME support for manufacturing sciences DP and packaging science.
• Drive process characterization, transfer, validation, and continuous improvement across sites.

Skills

Process science expertise

Technology transfer

Scale-up

Process validation

Regulatory interactions

Education

Master's degree in Pharmaceutical Science/C Chemistry/Chemical Engineering

Bachelor's degree in Pharmaceutical Science/Chemistry/Chemical Engineering

Tools

CMC content for dossiers

Job description

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will drive characterization, validation, and continuous improvement while coordinating cross-site activities and regulatory interactions. Qualified candidates hold an advanced degree with 8+ years of related experience, including design of development strategies, scale-up, and regulatory documentation.