Analytical Process Development Associate – HPLC/UPLC

Amgen SA

Thousand Oaks (CA)

On-site

USD 90,000 - 130,000

Full time

12 days ago
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Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Associate in Attribute Sciences to join a science-driven team focused on characterizing and quantifying therapeutic proteins. You will develop and qualify analytical methods (HPLC/UPLC/CE) and apply MS to support regulatory filings and quality control transfer.

As part of PD, you’ll collaborate across departments to enable robust manufacturing processes, perform stability studies, and explore new analytic technologies while maintaining

Qualifications

  • Bachelor’s degree, or an associate’s with 2 years of scientific experience, or a high school diploma with 4 years of scientific experience.
  • Experience in method development and product characterization for therapeutic proteins.
  • Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related field.
  • Strong written and verbal communication, multitasking, and teamwork skills.
  • Self-starter who values working in teams.

Responsibilities

  • Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis 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 to transfer and troubleshoot qualified methods.
  • Participate in the maintenance of Attribute Sciences instruments and assist GMP environment maintenance.
  • Coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions.
  • Conduct accelerated stability studies to define therapeutic degradative pathways.
  • Evaluate novel platform analytical technologies to drive innovation.
  • Perform experiments to answer questions from health authorities and collaborate with partner organizations on process development and validation studies.

Skills

Analytical chemistry
Biochemistry
Team collaboration
Excellent communication

Education

Bachelor's degree in a scientific field
Associate’s degree + 2 years scientific experience
High school diploma / GED + 4 years scientific experience

Tools

HPLC
UPLC
Capillary Electrophoresis
Mass Spectrometry (MS)

Job description

Amgen in Thousand Oaks, CA is seeking a Process Development Associate in Attribute Sciences to join a science-driven team focused on characterizing and quantifying therapeutic proteins. You will develop and qualify analytical methods (HPLC/UPLC/CE) and apply MS to support regulatory filings and quality control transfer.

As part of PD, you’ll collaborate across departments to enable robust manufacturing processes, perform stability studies, and explore new analytic technologies while maintaining

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