Process Science Manager: Tech Transfer & Validation Lead

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

Job summary

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to provide technical expertise for drug product manufacturing, serve as SME for major transfer/validation projects, and lead regulatory interactions including CMC content.

The role requires collaboration across sites and functions and may involve up to 5% travel with up to 65% remote work. Qualified candidates will have a Master’s or Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field

Qualifications

• Master’s or Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field with related experience.

Responsibilities

• Provide technical expertise within GMSci DP/Pkg organizations for drug product manufacturing.
• Lead major technical transfer or validation projects for new product introduction or lifecycle management.
• Lead regulatory interactions including CMC content for dossiers and ensure process knowledge sharing across sites.

Education

Master’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field

Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field

Job description

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to provide technical expertise for drug product manufacturing, serve as SME for major transfer/validation projects, and lead regulatory interactions including CMC content.

The role requires collaboration across sites and functions and may involve up to 5% travel with up to 65% remote work. Qualified candidates will have a Master’s or Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field