Process Development Associate, Biotech Analytics & GMP

Amgen SA

Thousand Oaks (CA)

Hybrid

USD 90,000 - 120,000

Full time

5 days ago

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Benefits offered by this job

Stock-based incentives

Generous time-off plans

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Associate to support protein characterization studies using CE, HPLC, and UPLC, and to transfer analytical methods to Quality Control. You will work with multiple teams to enable robust manufacturing processes for biologics.

The role emphasizes GMP-compliant practices and collaboration with Attribute Sciences to drive analytical innovation and support regulatory filings.

Qualifications

Bachelor’s degree OR Associate’s degree and 2 years of Scientific experience OR High school diploma / GED and 4 years of Scientific experience.

Responsibilities

Perform method development and qualification studies using HPLC, UPLC, and CE platforms.
Perform chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability studies.
Author results in laboratory notebooks and method development reports, interfacing with Attribute Sciences Team Leads and Quality Control.
Maintain instruments and support GMP environment within Attribute Sciences.
Coordinate and perform attribute identification and characterization studies, including isolation of chromatography fractions.
Conduct accelerated stability studies to define degradative pathways.
Evaluate novel analytical technologies to drive innovation.
Answer questions from health authorities through experiments.
Collaborate with partner organizations during development and validation studies.