Job Description SUMMARY Under general supervision, the Associate Manufacturing will perform manufacturing processes according to Standard Operating Procedures (SOP's). This role will be supporting a non-standard shift organization and is crucial for Amgen's success. Will be a key contributor in AML6 Media Preparation organization. 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 Good Manufacturing Practice (GMP's). Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports). Basic troubleshooting and initiate Quality incidents. Identify and recommend improvements related to routine functions and implement after approval. 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. Media preparation experience in pharmaceutical/biotechnology industry. Drug substance-Bulk Manufacturing and Biotechnology industry experience. Experience with UFDF/Aseptic Techniques / Laminar Flow Hood and/or Biosafety Cabinets. 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. Ability to interact constructively with peers. Ability to understand, applies, and evaluates basic chemistry, biology, and physical principles. Exhibits Amgen's values. Good communications skills. Bilingual (Spanish and English). 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 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.
Ciudad: juncos
