Process Development Scientist: Scale-Up & Tech Transfer

Amgen SA; Cambridge (MA); On-site; USD 112,000 - 145,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life insurance

Disability insurance

Annual bonus eligibility

Job summary

Amgen seeks a Process Development Scientist to support drug product commercialization and development across pipeline processes. You will apply biochemical and engineering principles to characterize, scale, and transfer processes from pilot to manufacturing, while contributing to lifecycle management and regulatory readiness.

The role involves cross-functional collaboration with engineering, analytical, quality, regulatory, and clinical teams, and may include telecommuting options.

Qualifications

• Master's degree required in a related field with 2 years' experience.
• Experience in statistical evaluation and data simulations.
• Experience with scale-up and technology transfer.
• Knowledge of regulatory filings and validation.
• Laboratory skills including aseptic handling and bench-scale operations.

Responsibilities

• Provide input to drug product commercialization and advancement of synthetic process development.
• Design, execute and document characterization studies and process transfer activities.
• Prepare module 3 regulatory documents and respond to information requests.
• Collaborate with cross-functional teams to ensure successful commercialization of processes.

Skills

Statistical evaluation

Process scale-up

Technology transfer

Regulatory documentation

Aseptic handling

Fill-finish operations

Education

Master's degree in Chemical Engineering/ Biochemical Engineering/ Biochemistry

Job description

Amgen seeks a Process Development Scientist to support drug product commercialization and development across pipeline processes. You will apply biochemical and engineering principles to characterize, scale, and transfer processes from pilot to manufacturing, while contributing to lifecycle management and regulatory readiness.

The role involves cross-functional collaboration with engineering, analytical, quality, regulatory, and clinical teams, and may include telecommuting options.