Career Category
ManufacturingJob Description
Job description (Senior Associate Manufacturing AR30)
Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world, with a long history of operational excellence and highly successful commercial and clinical operations. Amgen’s new plant, AR30, is responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative single use manufacturing platforms and technologies.
We are looking for a talented Senior Associate Manufacturing to join the manufacturing technical support function, focusing on floor support and projects in our Next Generation Bio-manufacturing plant AR30.
This individual contributor position reports into the Process Owner Manager as part the AR30 Manufacturing Support Team and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects.
Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing area. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations.
The Senior Associate Manufacturing will participate in cross-functional teams. This Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Manufacturing unit operations, SOPs, CAPA’s, Change controls and Deviations. In addition, the Senior Associate Manufacturing will initially identify, recommend, and implement improvements related to routine floor operations.
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:
- Single use technology experience
- Cell Culture Experience (troubleshooting critical processes)
- Purification Experience (troubleshooting critical processes)
- Cell culture and Purification Analytics experience
- Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment (Deviation / Nonconformance investigation writing experience)
- Deep understanding of analytical equipment used to support biotechnology manufacturing processes
- Understanding of analytical methods used for manufacturing area
- Regulatory knowledge and experience with regulatory audits
- Ability to interpret and apply GMP knowledge
- Mechanical expertise
- Knowledge of WIP lab equipment and computers, with LIMS access
- Statistical and mathematical skills
- Coding experience
- Ability to demonstrate technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on Manufacturing equipment including single use equipment
- Experience with Delta V/MES, PI data historian trending
- 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.
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