Process Science Manager — Tech Transfer & CMC (Remote)

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

Benefits offered by this job

Remote work option

Medical, dental, vision insurance

401(k) with company match

Paid time off and holidays

Incentive compensation programs

Job summary

Takeda Manufacturing USA, Inc. in Cambridge, MA seeks a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will serve as SME for major projects, oversee scale-up, validation, and regulatory interactions, and drive continuous improvement across sites and functions. Domestic and international travel are involved, with up to 65% remote work allowed.

Qualifications

• Master’s or Bachelor’s degree in a related field with relevant pharma experience.
• 8–10 years of related experience in drug product development, tech transfer or lifecycle management.
• Experience designing and executing formulation and process development strategies.
• Ability to translate processes across equipment and sites and develop comparability approaches.
• Familiarity with regulatory documentation to support manufacturing and regulatory requirements.

Responsibilities

• Provide SME expertise for major tech transfer or validation projects.
• Lead Drug Product Manufacturing Process Characterization, Tech Transfer, and validation activities.
• Lead regulatory interactions including CMC content for dossiers.
• Ensure process knowledge sharing across sites and functions.
• Manage projects to support Manufacturing Sciences DP and Packaging Science.
• Develop and implement continuous improvement strategies for marketed products.
• Collaborate with GMS Manufacturing Operating Unit and other functional groups.

Skills

Process development

Scale-up

Process validation

Analytical data analysis

Documentation

Cross-site collaboration

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. in Cambridge, MA seeks a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will serve as SME for major projects, oversee scale-up, validation, and regulatory interactions, and drive continuous improvement across sites and functions. Domestic and international travel are involved, with up to 65% remote work allowed.