Process Development Associate Large Molecule Release Testing

About the Role

Join Amgen's mission to serve patients living with serious illnesses by advancing innovative analytical tools to support the development of Amgen's therapies. Within Attribute Sciences, the Large Molecule Release Testing (LMRT) team supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment, collaborating with cross-functional partners on analytical method co-development, co-qualification, and transfer activities.

Key Responsibilities

• Cell culture maintenance.
• Reagents, media, and buffer preparation.
• Routine laboratory maintenance, including restocking, ordering, and assisting with safety actions and audit readiness.
• Performing cell-based assays, binding assays, ELISA, and qPCR assays.
• Generating robust and reliable data, and organizing/reporting data in a validated system.
• Supporting method hand-off and troubleshooting.
• Supporting critical reagents freezer inventory management through manual counts and maintenance of tracking records.

Requirements & Tech Stack

• GMP environment
• Cell culture
• Cell-based assays
• Binding assays
• ELISA
• qPCR
• Analytical method development
• Analytical method qualification
• Analytical method transfer
• Documentation (including understanding of GxP Requirements)
• Communication (oral and written)
• Attention to detail
• Teamwork skills

Qualifications

• Basic Qualifications:
• Bachelors degree OR
• Associates degree and 2 years of Scientific experience OR
• High school diploma / GED and 4 years of Scientific experience
• Preferred Qualifications:
• B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or related technical subject area.
• Demonstrated ability in the biotech industry, including GxP regulations.
• Experience in cell culture, cell-based bioassay, binding assays, immunoassays, and qPCR.
• Experience developing, qualifying, and testing analytical methods.
• Excellent teamwork skills working in a fast-paced GMP environment.
• Excellent Documentation Skills, including an understanding of GxP Requirements.
• Excellent communication (oral and written) skills and attention to detail.