Senior Process Development Scientist - LC-MS & GMP (Remote)

Amgen Inc.

Thousand Oaks (CA)

Hybrid

USD 91,000 - 108,000

Full time

3 days ago
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Benefits offered by this job

Stock options
Retirement plan
Medical, dental, vision coverage
Life and disability insurance
Annual bonus
Stock-based incentives
Flexible work models

Job summary

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate to advance analytical method development for protein analytics, including HPLC, UHPLC and CE workflows. You will collaborate with Attribute Sciences and Quality Control to transfer qualified methods and support product characterization in a GMP environment.

The role emphasizes data analysis, instrument troubleshooting, and cross-functional teamwork to drive scalable process development and regulatory readiness.

Qualifications

  • Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field with 2 years of related experience.
  • Analytical chemistry experience for protein molecules and data/results analysis using Empower, Chromeleon & ChemStation.
  • LC/LC-MS/CE analytics, method development and transfer experience.
  • Method qualification and transfer for analytical instruments with data analysis and statistics.
  • GLP standards and SOP implementation in a laboratory setting.
  • Laboratory notebook documentation of experiments and results.

Responsibilities

  • Perform method development and qualification studies using HPLC, UHPLC, and CE platforms.
  • Perform chromatographic fractionation, peptide mapping, intact mass, and LC-MS studies for characterization.
  • Author results in notebooks and lab reports; interface with QA to transfer methods.
  • Maintain Attribute Sciences instruments and GMP-compliant environment.
  • Evaluate critical quality attributes and coordinate identification studies.
  • Conduct accelerated stability studies to define degradative pathways.
  • Evaluate novel analytical technologies to drive innovation.
  • Collaborate with partner organizations during process development and validation.

Skills

Analytical chemistry
Protein chemistry
Data analysis
Statistical evaluation
GLP compliance
Laboratory documentation
Instrument troubleshooting
Method development

Education

Bachelor’s degree in Chemistry, Chemical Biology or related field

Tools

Empower
Chromeleon
ChemStation
Waters instruments
Agilent instruments
SoloVPE

Job description

Amgen Inc. in Thousand Oaks, CA is seeking a Process Development Associate to advance analytical method development for protein analytics, including HPLC, UHPLC and CE workflows. You will collaborate with Attribute Sciences and Quality Control to transfer qualified methods and support product characterization in a GMP environment.

The role emphasizes data analysis, instrument troubleshooting, and cross-functional teamwork to drive scalable process development and regulatory readiness.

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