Amgen Associate Manufacturing in Rhode Island, Rhode Island
Under general supervision, Associate Manufacturing will perform operations in the Manufacturing area, specifically Purification processes. 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 Manufacturing Procedures, SOPs, and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Associate may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, Associate may identify, recommend, and implement improvements related to routine functions.
A Shift Schedule: 7:00am - 7:00pm Rotating Days
Basic Qualifications :
Bachelor's degree or completed by June 2019
Associate's degree and 4 years of Manufacturing or Operations experience
High School diploma/GED and 6 years of Manufacturing or Operations experience
Knowledge of large-scale Purification operations, chromatography, TFF, aseptic processing, etc.
CFR and Regulatory knowledge
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 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 Purification equipment
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.