Shift Schedule: 7:00am - 7:00pm
Under general supervision, employee will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Employee may also have the responsibility of owning NC/CAPAs and Change Control records. In addition, employee may identify, recommend, and implement improvements related to routine functions.
Associate's degree & 4 years of Manufacturing & Operations related experience
High School diploma/GED & 6 years of Manufacturing & Operations related experience.
- Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, etc.
- 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 Purification equipment
- Experience with Delta V, RDs
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.