Analytical Process Development Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus program

Stock incentives

Time-off flexibility

Flexible work model

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Associate to participate in protein characterization studies supporting regulatory filings using CE, HPLC/UPLC and MS. The PD team optimizes analytical methods and transfers them to Quality Control, enabling robust manufacturing processes.

You will collaborate across departments to support marketing applications, perform method development and qualification studies, and contribute to GMP-compliant operations in a fast-paced,

Qualifications

• Bachelors degree
• Associates degree and 2 years of Scientific experience
• 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 closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods
• Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase appropriate GMP environment
• With a focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions
• Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways
• Perform evaluation of novel platform analytical technologies to help drive innovation
• Perform experiments to help answer questions from health authorities
• Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications

Education

Bachelors degree

Associates degree and 2 years of Scientific experience

High school diploma / GED and 4 years of Scientific experience

Job description

Amgen in Thousand Oaks, CA is seeking a Process Development Associate to participate in protein characterization studies supporting regulatory filings using CE, HPLC/UPLC and MS. The PD team optimizes analytical methods and transfers them to Quality Control, enabling robust manufacturing processes.

You will collaborate across departments to support marketing applications, perform method development and qualification studies, and contribute to GMP-compliant operations in a fast-paced,