Process Development Associate
Amgen
About the Role
Amgen is seeking a Process Development Associate for their Large Molecule Release Testing team. This role is within the Biologics Attribute Sciences function, supporting release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The team collaborates with cross-functional partners for analytical method co-development, co-qualification, and method transfer.
Key Responsibilities
- Cell culture maintenance, reagents/media/buffer preparation, and relevant support.
- 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, organizing and reporting data in a validated system.
- Supporting method hand-off and troubleshooting.
- Supporting critical reagents freezer inventory management through detailed manual counts and maintenance of inventory tracking records.
Requirements & Tech Stack
- Cell culture
- Cell-based bioassay
- Binding assays
- Immunoassays
- qPCR
- Developing, qualifying, and testing analytical methods
- GxP regulations
- GMP environment
- Documentation skills
- Communication (oral and written) skills
- Attention to detail
Qualifications
- Basic Qualifications:
- Bachelor’s degree OR
- Associate’s 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 but not limited to GxP regulations.
- Excellent teamwork skills.