Senior Process Development Scientist — Biologics & Scale-Up

BioSpace; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Stock-based incentives

Flexible work models

Job summary

Amgen in the United States seeks a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes enabling program progression from Phase II/III to filing.

You will collaborate with cell culture and purification scientists across modalities to advance Amgen's rich pipeline, delivering robust processes in a regulated, cGMP environment and contributing to regulatory documentation.

Qualifications

• PhD or MSc with Life Sciences experience; strong biology/bioprocess background.
• Experience in bioreactor process development or cell line development.
• Knowledge of DOE and statistical data analysis.
• Exposure to cGMP manufacturing and regulatory submissions (CMC).

Responsibilities

• Develop, characterize, scale-up and support drug substance processes.
• Collaborate with cell culture and purification Scientists to advance programs.
• Contribute to technology development and process improvements.
• Deliver processes in a phase-appropriate manner for cGMP operation.
• Prepare technical reports and contribute to CMC regulatory submissions.

Skills

Technical communication

Leadership

Experiment design

Statistical analysis

Problem solving

Cross-functional collaboration

Education

Doctorate degree

Masters degree + Life Sciences experience

Bachelors degree + Life Sciences experience

Job description

Amgen in the United States seeks a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes enabling program progression from Phase II/III to filing.

You will collaborate with cell culture and purification scientists across modalities to advance Amgen's rich pipeline, delivering robust processes in a regulated, cGMP environment and contributing to regulatory documentation.