Shift Schedule: A Shift, 7:00am - 7:00pm rotating days
Under general supervision, employee will perform operations in the Perfusion, Production and Harvest (PPH) area. 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 Batch Records, SOPs, and technical reports. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent PPH group. Employee may also have the responsibility of owning NC/CAPA's. May identify, recommend, and implement improvements related to routine functions.
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 biotechnology operations such as purification, cell culture, aseptic processing, etc.
CFR and Regulatory knowledge
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
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 production equipment
Experience with Delta V
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. Associated topics: bio, biology, biophysics, bioprocessing, biosynthetic, fermentation, hereditary, metabolic, neuro, pain