Biologics Attribute Sciences Associate - Process Dev

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 100,000 - 150,000; Full time

Job summary

Amgen, located in Thousand Oaks, CA, is seeking a Process Development – Pre-Pivotal Biologics Attribute Sciences Associate to join our analytical development team. You will collaborate closely with Attribute Sciences Team Leads and cross-functional partners to support development and characterization of novel biotherapeutics.

You will perform analytical studies, develop methods, and interpret results to advance programs toward the clinic.

Qualifications

• Bachelor's degree or equivalent.
• Associate's degree plus 2 years of scientific experience.
• High school diploma with 4 years of scientific experience required.
• Preferred: Biochemistry, Biophysics, Analytical Chemistry, Protein Chemistry, Bioengineering, Biotechnology, Pharmaceutical Sciences or related fields.

Responsibilities

• Perform analytical testing and characterization studies to evaluate product quality attributes and stability.
• Co-verify and qualify analytical methods to enable GMP lab execution and validation.
• Support testing of drug substance, drug product, and development materials for formulation and stability studies.
• Conduct product characterization studies using fraction collection and degradations to interrogate quality attributes.
• Analyze and document experimental data with guidance from ASTLs and cross-functional partners.
• Prepare technical reports, regulatory documentation, and presentations from data analyses.

Skills

Analytical thinking

Problem-solving

Troubleshooting

Data analysis

Communication skills

Digital tools for data analysis

Automation in analysis

GDP compliance

Education

Bachelor's degree

Associate's degree + 2 years scientific experience

High school diploma / GED + 4 years scientific experience

Biochemistry/related fields

Tools

Data visualization

Data management

Automation tools

Job description

Amgen, located in Thousand Oaks, CA, is seeking a Process Development – Pre-Pivotal Biologics Attribute Sciences Associate to join our analytical development team. You will collaborate closely with Attribute Sciences Team Leads and cross-functional partners to support development and characterization of novel biotherapeutics.

You will perform analytical studies, develop methods, and interpret results to advance programs toward the clinic.