HOW MIGHT YOU DEFY IMAGINATION?
You’veworked 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 over10 million patientsworldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 AssociateManufacturing- Bulk Drug Substance Downstream-Nights
Live
What youwill do
Let’sdo this.Let’schange the world. In this dynamic role,you will beaSenior Associate inthemanufacturing organization atAmgenNorth Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pmto6:15am. Associates will be executing operations on the floorin 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.
Responsibilitieswill include…
Compliance:
Completes workin accordance withestablished 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 asneeded andguided
Assure proper gowning and aseptic techniques arealways followed
Process/Equipment/Facilities:
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Perform hands-ondownstream biotechoperations(Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others)including set-up,operation,cleaning, sanitization,monitoringof equipment and assigned area
Runandmonitorcritical process tasksperassigned procedures
Perform in-process sampling,operateanalytical equipment, andcompleteprocess documentation(ElectronicBatchRecords[EBR])
Completewashroom activities:cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing relatedprocessdeviations
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
Assistin the review ofdocumentation for assigned functions (i.e.,equipment logs,EBRs)
Collaborateas part of across-functional team (i.e.,QA/QC,F&E (Facilities & Engineering), PPIC,Mfg.,PD (Process Development), Regulatory, etc.) in completing production activities
Responsible forrecognizing andelevating 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, andassistthe 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 managementas an advisorin planningandinescalatingpotential concerns withtheschedule and/or process
Win
What we expectofyou
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