SUMMARY Under general supervision, the Associate Mfg will perform manufacturing processes according to Standard Operating Procedures (SOP's). This role will be supporting a non-standard shift organization and will be a key contributor in AML6-Purification organization. Multiple positions are available. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Support non-standard shifts organization (first, second, third, twelve hours and/or weekend shifts), as per business needs Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures Perform and monitor critical processes Execute routine validation protocols Comply with GMP's Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports) Initiate Quality incidents Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize & accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May train staff to perform hands-on tasks May act as safety representative May assist with system ownership responsibilities EDUCATION/LICENSES Basic Education & Experience Bachelor's degree PREFERRED QUALIFICATIONS Educational discipline in Life/Natural Science and/or Engineering Minimal manufacturing experience in a Biotechnology industry Experience with protein purification process Experience with UFDF/Aseptic Techniques / Laminar Flow Hood and/or Biosafety Cabinets Experience in Operational Excellence Program Basic knowledge in Quality System Program Ability to assemble, disassembles, operate and understand complex equipment per procedures Experience with lab equipment and computers Intermediate mathematical skills Clear, concise writing skills Organizational skills Basic problem solving skills Basic knowledge in Root Cause Analysis Basic communication skills and Microsoft Office Ability to interact constructively with peers Ability to understand, applies, and evaluates basic chemistry, biology, and physical principles Exhibits Amgen's values 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. Join Us If 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. .
