Process Development Associate

About the role

Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the quality characteristics of its therapies and optimizes analytical tools to guide their development. The Pivotal PD organization develops and commercializes robust manufacturing processes for biologics such as monoclonal and bispecific antibodies, BiTEs, antibody-drug conjugates, live oncolytic viruses and synthetic medicines. As a PD Associate, you will run protein characterization studies supporting regulatory filings and help develop, qualify and transfer analytical methods to Quality Control. The position is based at the Thousand Oaks, CA site.

Key responsibilities

• Perform method development and qualification studies using HPLC, UPLC and CE platforms
• Run chromatographic fractionation, peptide mapping, intact mass and other LC-MS studies for product characterization and comparability
• Write results in laboratory notebooks and method development reports, and work with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods
• Maintain Attribute Sciences instruments and help keep a GMP-compliant environment
• Coordinate and run attribute identification and characterization studies, including isolation and analysis of chromatography fractions
• Conduct and coordinate accelerated stability studies to define degradative pathways
• Evaluate novel platform analytical technologies and run experiments to answer questions from health authorities
• Collaborate with partners on commercial process development, characterization and validation studies

Required profile

• Bachelor's degree, or an Associate's degree plus 2 years of scientific experience, or a high school diploma / GED plus 4 years of scientific experience
• Preferred: scientific background in method development and product characterization for therapeutic proteins
• Preferred: degree in Biochemistry, Analytical Chemistry, Protein Chemistry or a related field
• Excellent written and verbal communication, multitasking, planning and follow-through
• A self-starter who values teamwork

Required skills

• HPLC, UPLC and CE method development and qualification
• LC-MS studies (peptide mapping, intact mass)
• Accelerated stability studies

What we offer

• Annual salary range of $74,503.35 to $100,798.65, depending on skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans and flexible work models where possible