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Job description
Senior Associate Manufacturing - Bulk Drug Substance DownstreamJoin Amgen's Mission of Serving PatientsYou've worked hard to become the professional you are today and are now ready to take the next step in your career. 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.What you will doLet'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, this 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 complianceInitiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observationsInteract with regulatory agencies as needed and guidedAssure proper gowning and aseptic techniques are always followedOperational Readiness & Facility StartupSupport operational readiness activities for facility expansion and startupExecute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughsParticipate in commissioning, qualification, and startup activities as trained and assignedProvide operational feedback during startup activities to support safe, compliant, and efficient manufacturingSupport readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp-upProcess/Equipment/Facilities:Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned areaRun and monitor critical process tasks per assigned proceduresPerform 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 activitiesIdentify, recommend, and implement innovative process improvements and optimizations related to daily routine functionsAssist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activitiesResponsible for recognizing and elevating problems during daily operationsParticipate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvementDrive safety in all operations, and assist the manager in escalating concerns as neededMaintain an organized, clean, and workable spaceAdministrative: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 processWhat we expect of youWe 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 ORAssociate's Degree + 2 years manufacturing and/or other regulated environment experience ORBachelor's Degree + 6 months manufacturing and/or other regulated environment experience ORMaster's DegreePreferred Qualifications :Completion of NC BioWorks Certification ProgramExperience in biotechnology or pharmaceutical plant start upKnowledge and process experience within a cGMP manufacturing facility or other highly regulated environmentUnderstanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)Excellent verbal and written communication (technical) skillsProficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality SystemsWhat you can expect of usAs 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, and career development opportunities including:Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possible
Worksite address
holly springs, NC, 27540, US
Who can apply
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