Career Category

Job Description

A-shift (Day rotation 7AM-7PM)

Under minimal supervision the Senior Associate will perform operations in the Purification area per Standard Operating Procedures. Responsible to perform and monitor critical processes (Chromatography, UF/DF, Viral inactivation/filtration, LFH Operations, WIP Lab operations, SIP and CIP), execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, TR/CAPA, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the Purification manager as well as perform complex troubleshooting.  Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing the Purification Department.

Basic Qualifications

Master’s degree

OR

Bachelor’s degree and 2 years of Manufacturing or Operations experience

OR

Associate’s degree and 6 years of Manufacturing or Operations experience

OR 

High school diploma / GED and 8 years of Manufacturing or Operations experience

Preferred Qualifications:

• Knowledge of Purification operations
• Knowledge of WIP lab equipment and computers
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for Manufacturing area
• Ability to demonstrate technical writing skills (Trackwise experience)
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills
• Experience with Delta V, RDs, and the PI system

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.