Senior Analytical Process Development Scientist

Amgen; Thousand Oaks (CA); Hybrid; USD 91,000 - 108,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life insurance

Disability insurance

Annual bonus

Sales incentive programs

Flexible work models (remote/ hybrid)

Job summary

Amgen's Process Development team in Thousand Oaks seeks a Process Development Associate to perform method development and qualification using HPLC, UHPLC, CE, and LC-MS to support product characterization and comparability studies.

You will document results, transfer methods with QA, help maintain GMP environment, and collaborate across teams on process development, characterization, and validation to support marketing applications.

Qualifications

• Bachelor’s degree in Chemistry or related field with 2+ years of relevant experience.
• Analytical chemistry experience for protein molecules and degradation studies.
• Experience with HPLC/LC-MS/CE and instrument troubleshooting.
• Ability to design, execute and transfer analytical methods with data analysis.
• GLP environment experience and accurate lab notebook documentation.

Responsibilities

• Perform method development and qualification studies using HPLC, UHPLC, and CE.
• Conduct LC-MS studies to support protein characterization and comparability.
• Document results in notebooks and transfer through QA to operations.
• Maintain Attribute Sciences instruments and GMP-compliant environment.
• Evaluate quality attributes and perform attribute identification and characterization.
• Coordinate accelerated stability studies and define degradative pathways.
• Explore novel analytical technologies to drive innovation.
• Address questions from health authorities through experiments and analyses.
• Collaborate with partner organizations during process development, characterization, and validation.

Skills

Analytical chemistry for proteins

Data analysis

GLP knowledge

Documentation in notebooks

Education

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

Tools

HPLC/UHPLC

Capillary Electrophoresis (CE)

LC-MS

Empower

Chromeleon

ChemStation

Waters instruments

Agilent instruments

Maurice software

Job description

Amgen's Process Development team in Thousand Oaks seeks a Process Development Associate to perform method development and qualification using HPLC, UHPLC, CE, and LC-MS to support product characterization and comparability studies.

You will document results, transfer methods with QA, help maintain GMP environment, and collaborate across teams on process development, characterization, and validation to support marketing applications.