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/CAPAs and Change Control records. In addition, Associate may identify, recommend, and implement improvements related to routine functions.
- Bachelor's degree
- 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 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, RDs
- 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.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.