Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients   You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.   Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.     Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days Live   What you will do     Let’s do this! Let’s change the world! In this dynamic role, you will be an Senior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup . This essential role will be part of a team responsible for manufacturing  downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill  ,   while partnering across functions to ensure successful operational readiness, technology transfer, and ramp ‑ up of manufacturing operations within the new facility.     This role may require work outside standard business hours, including non ‑ standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.   During this phase of the startup, you will be expected to  work  a Monday – Friday schedule from 8am – 5 pm.   As the business moves from C&Q to manufacturing operations, this essential position   will   work on   a 12-hour 2-2-3 schedule from 5:45 am to   6:15pm   supporting our critical 24/7 manufacturing operations.    As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, th is role must be able to work assigned 12-hour   shift, including during inclement weather, some holidays and requested overtime in support of our operations.   During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.       Compliance:    Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance   Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations   Interact with regulatory agencies as needed and guided   Assure proper gowning and aseptic techniques are always followed   Operational Readiness & Facility Startup   Support operational readiness activities for facility expansion and startup   Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs   Participate in commissioning, qualification, and startup activities as trained and assigned   Provide operational feedback during startup activities to support safe , compliant , and