Remote Process Development Scientist: Tech Transfer & Lifecycle

BioSpace; 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 is seeking a Process Development Scientist to support drug product commercialization and ongoing process development across clinical and commercial facilities. You will design studies, transfer processes, and author technical documents while collaborating with cross-functional teams to ensure successful lifecycle management.

The role requires a Masters degree in a relevant field and 2 years of related experience, with emphasis on statistical analysis, scale-up, and regulatory

Qualifications

• Masters degree in Chemical Engineering, Biochemical Engineering, Biochemistry or related field with 2 years' experience.
• Experience applying statistics to evaluate data and process capability.
• Experience with scale-up, technology transfer, and process validation.
• Experience writing regulatory documents and responses for health authorities.

Responsibilities

• Provide input and support to drug product commercialization and process development.
• Design and execute characterization studies and data packages for technology transfer.
• Support regulatory submissions and lifecycle management across clinical and commercial facilities.
• Collaborate with cross-functional teams to apply Amgen platforms and capabilities.

Skills

Statistical analysis

Process scale-up

Technology transfer

Regulatory filings

Bench-scale testing

Cross-functional collaboration

Education

Master's degree in Chemical/ Biochemical Engineering or related field

Job description

Amgen is seeking a Process Development Scientist to support drug product commercialization and ongoing process development across clinical and commercial facilities. You will design studies, transfer processes, and author technical documents while collaborating with cross-functional teams to ensure successful lifecycle management.

The role requires a Masters degree in a relevant field and 2 years of related experience, with emphasis on statistical analysis, scale-up, and regulatory