Senior Process Development Scientist, Biologics & Bioprocess

Amgen SA; Cambridge, Northern (MA, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Amgen is hiring a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes to advance programs from Ph II/III through regulatory submission.

You will work in a cross-functional team with bioprocessing, analytical and regulatory colleagues, expanding cell culture and purification capabilities while delivering cGMP-compliant processes and impactful scientific contributions.

Qualifications

• Doctorate degree in Life Sciences or related field.
• Master’s degree with 2+ years of Life Sciences experience.
• Bachelor’s degree with 4+ years of Life Sciences experience.

Responsibilities

• Apply platform approaches to tackle drug substance challenges and build robust processes.
• Drive innovation and develop new approaches to bioreactor technology.
• Expand skills in cell culture and purification to support the pipeline.
• Collaborate cross-functionally with analytical and drug product teams.
• Deliver processes suitable for cGMP operation in manufacturing.
• Prepare technical reports or regulatory submissions (CMC) with minimal edits.

Skills

Leadership

Technical communication

Problem solving

Bioprocessing knowledge

Education

Doctorate degree

Master’s degree + Life Sciences experience

Bachelor’s degree + Life Sciences experience

Job description

Amgen is hiring a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes to advance programs from Ph II/III through regulatory submission.

You will work in a cross-functional team with bioprocessing, analytical and regulatory colleagues, expanding cell culture and purification capabilities while delivering cGMP-compliant processes and impactful scientific contributions.