Amgen Associate Manufacturing in Rhode Island, Rhode Island
Rotating Shift Schedule: D shift, 7:00pm - 7:00am
Under general supervision, staff member will perform operations in the Inoculum, Seeds, Perfusion, Production and Harvest areas. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Batch Records, SOPs, and technical reports. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent PPH group. Employee may also have the responsibility of owning NC/CAPA’s. May identify, recommend, and implement improvements related to routine functions.
Basic Qualifications :
Associate’s degree and 4 years of Manufacturing or Operations experience
High school diploma / GED and 6 years of Manufacturing or Operations experience
Preferred Qualifications :
Knowledge of cell culture operations and bioreactors
Knowledge of analytical equipment and computers
CFR and Regulatory knowledge
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate technical writing capability
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Basic troubleshooting skills on process equipment
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.