Career Category

Job Description

D Shift: 7 pm to 7 am, Rotating Nights

Under minimal supervision, the Senior Associate will perform and monitor critical processes, execute routine qualification and validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, deviations/CAPAs, and technical reports. The Senior Associate will provide leadership to the team per the direction of the area manager as well as perform complex troubleshooting.  Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate in cross-functional teams while representing their home department. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

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 small-scale bioreactors, wave bioreactors, and aseptic processing.
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for the manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• Able to demonstrate project management skills and presentation skills
• Independently collaborate with outside resources
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on bioreactors
• Experience with Delta V, RD’s
• Experience with lab equipment/testing

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.