Career Category
OperationsJob Description
Shift Schedule: 7:00pm - 7:00am Rotating Nights
Under general supervision, Associate Manufacturing will perform operations in the Manufacturing area, specifically Inoc/Seeds. 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 Inoc/Seeds 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.
Basic Qualifications:
- Bachelor's degree
- OR
- Associate's degree and 4 years of Manufacturing or Operations experience
- OR
- High School diploma/GED and 6 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 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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
Get email alerts for the latest"Associate Manufacturing-Nights jobs in Us - rhode island - west greenwich"