Amgen Associate Manufacturing in Rhode Island, Rhode Island
Rotating Shift Schedule: C shift, 7:00pm – 7:00am
Amgen Rhode Island (ARI) is a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. We are looking for candidate who, under general supervision, will be responsible for supporting GMP operations in the manufacturing organization within Perfusion, Production and Harvest area.
Efficiently perform and monitor critical GMP manufacturing operations in accordance with Standard Operating Procedures (SOPs).
Effectively use and perform basic troubleshooting within the site’s electronic systems (e.g., and Manufacturing Execution System (MES), Delta V, and Enterprise Resource Planning (ERP) system).
Execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
Contribute to the culture of safety and quality by participating in and leading team safety and quality initiatives.
Understand and contribute to the team’s Lean Manufacturing goals and objectives by identifying improvement opportunities and implementing solutions.
Work with diverse teams
Escalate issues appropriately.
Ownership of corrective and preventative action and non-conformance records.
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.
Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, etc.
Knowledge of large scale cell culture operations.
CFR and Regulatory knowledge.
Mechanical ability/expertise on fed-batch manufacturing equipment.
Knowledge of WIP lab equipment and computers, with LIMS access.
Demonstrated strong work ethic and positive attitude.
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.
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.