Process Development Associate – Molecule Release Testing

Process Development Associate – Large Molecule Release Testing

Join to apply for the Process Development Associate – Large Molecule Release Testing role at Amgen.

Amgen’s mission is to serve patients living with serious illnesses. Since 1980, we have pioneered biotechnology to fight the world’s toughest diseases across four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the team, you’ll help research, manufacture, and deliver innovative medicines that improve patient lives.

Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines critical quality attributes and advances analytical tools. In the Large Molecule Release Testing (LMRT) team, you will support release and stability testing of toxicology and clinical batches in a phase‑appropriate GMP environment, collaborate with cross‑functional partners, and contribute to method co‑development, co‑qualification, and method transfer.

• Cell culture maintenance, reagents/media/buffer preparation, and relevant support.
• Routine laboratory maintenance such as restocking, ordering, and safety/audit readiness.
• Perform cell‑based assays, binding assays, ELISA, and qPCR.
• Generate robust data, organize and report data in a validated system with minimal direction.
• Support method hand‑off and troubleshooting.
• Maintain monthly Work Order tracking for PM and calibration activities using Maximo.
• Manage critical reagent extensions, review monthly needs, submit requests with assay data, update COA.
• Maintain reagent freezer inventory through manual counts and record keeping.
• Coordinate monthly pipette calibration, verify WO closure, and initiate HLEE investigations for out‑of‑tolerance results.

• High school diploma / GED and 4 years of scientific experience OR Associate’s degree and 2 years of scientific experience OR Bachelor’s degree.

• B.S. or M.S. in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or related area.
• Experience in the biotech industry, including GxP regulations.
• Experience in cell culture, cell‑based bioassay, immunoassays, and qPCR.
• Experience developing, qualifying, and testing analytical methods.
• Excellent documentation skills, understanding of GxP requirements.
• Excellent communication and attention to detail.

We support your professional and personal growth through competitive benefits, a comprehensive rewards plan, retirement contributions, health coverage, flexible work models, and career development opportunities.

Seniority level:
Not Applicable.

Employment type:

Full-time. Job function:
Research, Analyst, and Information Technology. Industries:
Biotechnology Research and Pharmaceutical Manufacturing.

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for doing so.

Apply now and make a lasting impact with the Amgen team.

Amgen is an Equal Opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected characteristic. Reasonable accommodations are available for applicants with disabilities.