Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Career CategoryManufacturingJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?   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 - Nights  Live What you will do   Let’s do this. Let’s change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC).  The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Associates will be executing operations on the floor in our downstream        area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.    With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.    Responsibilities will include…   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 non-conformance (NC) reports  Interact with regulatory agencies as needed and guided  Assure proper gowning and aseptic techniques are always followed  Process/Equipment/Facilities:  Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Initiate and own manufacturing related process deviations Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities  Responsible for recognizing and elevating problems during daily operations  Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement    Drive safety in all operations, and assist the manager in escalating concerns as needed   Maintain an organized, clean, and workable space  Administrative:  Draft and revise documents (SOPs, technical reports, and MPs) Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process   Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.  Basic Qualifications: High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience  Or​ Associate’s Degree + 2 years manufacturing and/or other regulated environment experience  Or​ Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience  Or Master's ​Degree  Preferred Qualifications: Completion of NC BioWorks Certification Program Experience in biotechnology or pharmaceutical plant start up  Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment   Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Excellent verbal and written communication (technical) skills Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems   Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.  The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, a