Senior Scientist, Process Development – Biologics Analytics

Amgen; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Amgen's Cambridge, MA team seeks a Process Development Senior Scientist in Attribute Sciences to advance analytical methods monitoring CQAs and support process characterization for biologics.

You will lead protein characterization and LC/MS studies, develop automation-enabled workflows, and contribute to regulatory submissions. A PhD or equivalent with deep analytical expertise in biologics and strong communication is required.

Qualifications

• PhD or equivalent required with strong background in biologics and analytics.
• Experience with pharmaceutical process development and analytical support.
• Ability to author and review regulatory documents for IND/BLA submissions.

Responsibilities

• Develop, optimize, troubleshoot, qualify, validate, and transfer analytical methods for monitoring critical quality attributes and supporting process characterization, comparability assessments, investigations, and control-strategy development.
• Lead late-stage protein characterization, structural elucidation, and forced degradation studies using high-resolution LC/MS, including peptide mapping and intact mass analysis.
• Establish robust, automation-ready analytical workflows spanning sample prep, instrument integration, data processing, and report generation to reduce hands-on time and increase lab efficiency.
• Interpret complex analytical data and author or review technical and regulatory documents for INDs and BLAs.
• Provide analytical SME expertise and technical guidance to cross-functional partners.

Skills

Analytical method development

LC/MS

Protein characterization

Automation

Regulatory submissions (IND/BLA)

Technical writing

Team collaboration

Problem solving

Independent worker

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Tools

Thermo Orbitrap

Chromeleon

Biopharma Finder

Job description

Amgen's Cambridge, MA team seeks a Process Development Senior Scientist in Attribute Sciences to advance analytical methods monitoring CQAs and support process characterization for biologics.

You will lead protein characterization and LC/MS studies, develop automation-enabled workflows, and contribute to regulatory submissions. A PhD or equivalent with deep analytical expertise in biologics and strong communication is required.