Process Development Senior Scientist - Attribute Sciences
Amgen
August 13, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Senior Scientist – Attribute Sciences
What You Will Do
- 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 (peptide mapping, disulfide mapping, and intact mass analysis).
- Establish robust, automation-ready analytical workflows (sample preparation, instrument integration, data processing, report generation) to reduce hands-on time and increase lab efficiency.
- Interpret complex analytical data; author or review technical and regulatory documentation including analytical methods, protocols, reports, and CMC sections for INDs and BLAs.
- Provide analytical subject-matter expertise and technical guidance to cross-functional partners.
Basic Qualifications
- Doctorate degree
OR
- Master’s degree and 2 years of scientific experience
OR
- Bachelor’s degree and 4 years of scientific experience
Preferred Qualifications
- 3+ years in pharmaceutical process development with analytical support, method execution, and investigational testing.
- Expertise in analytical method development and structural/physicochemical characterization of biologics (mAbs, fusion proteins, protein conjugates such as ADCs).
- Deep LC/MS expertise (bottom-up peptide mapping incl. disulfide mapping; intact mass analysis), with strong sample prep/artifact control and MS/MS interpretation.
- Hands-on Thermo Orbitrap experience (maintenance, calibration, troubleshooting); Chromeleon and Biopharma Finder a plus.
- Hands-on laboratory automation experience (liquid handlers, pipetting robots, automation software).
- Regulatory submission experience (module 3/Quality for IND/BLA submissions).
- Strong written/verbal communication; translates complex data into clear recommendations.
- Proactive independent self-starter; strong problem-solving/decision-making; prioritizes and manages multiple complex projects.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- 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 (peptide mapping, disulfide mapping, and intact mass analysis).
- Establish robust, automation-ready analytical workflows (sample preparation, instrument integration, data processing, report generation) to reduce hands-on time and increase lab efficiency.
- Interpret complex analytical data; author or review technical and regulatory documentation including analytical methods, protocols, reports, and CMC sections for INDs and BLAs.
- Provide analytical subject-matter expertise and technical guidance to cross-functional partners.
Basic Qualifications
- Doctorate degree
OR
- Master’s degree and 2 years of scientific experience
OR
- Bachelor’s degree and 4 years of scientific experience
Preferred Qualifications
- 3+ years in pharmaceutical process development with analytical support, method execution, and investigational testing.
- Expertise in analytical method development and structural/physicochemical characterization of biologics (mAbs, fusion proteins, protein conjugates such as ADCs).
- Deep LC/MS expertise (bottom-up peptide mapping incl. disulfide mapping; intact mass analysis), with strong sample prep/artifact control and MS/MS interpretation.
- Hands-on Thermo Orbitrap experience (maintenance, calibration, troubleshooting); Chromeleon and Biopharma Finder a plus.
- Hands-on laboratory automation experience (liquid handlers, pipetting robots, automation software).
- Regulatory submission experience (module 3/Quality for IND/BLA submissions).
- Strong written/verbal communication; translates complex data into clear recommendations.
- Proactive independent self-starter; strong problem-solving/decision-making; prioritizes and manages multiple complex projects.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.