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Job description
Associate Manufacturing - Bulk Drug Substance Upstream - DaysHOW 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.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.With general direction, the Associate will support all floor operations in accordance with cGMP practices.Key ResponsibilitiesCompliance & QualityExecute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRsEnsure proper gowning and aseptic techniques are consistently followedInitiate and document manufacturing related deviations and quality events as trainedSupport investigations and corrective actions under guidanceMaintain a strong culture of safety, quality, and complianceOperational Readiness & Facility StartupSupport operational readiness and facility startup activities as part of the expansion programParticipate in training, equipment familiarization, and procedure execution to enable startupExecute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operationsFollow defined workflows and procedures to support safe and compliant startup activitiesProvide operational feedback and escalate issues observed during startup executionManufacturing OperationsPerform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areasRun and monitor critical process tasks per approved proceduresPerform in process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)Complete washroom activities for small-to large-scale manufacturing equipmentIdentify and escalate operational issues impacting safety, quality, or scheduleMaintain an organized, clean, and compliant manufacturing environmentWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.Basic Qualifications:High School/GED + 2 years manufacturing and/or other regulated environment experienceOrAssociate's Degree + 6 months manufacturing and/or other regulated environment experienceOrBachelor's DegreePreferred Qualifications:Completion of NC BioWork / BioWorks Certification ProgramExperience in a regulated industry such as biotechnology or pharmaceutical manufacturingBasic understanding of cGMP manufacturing environmentsFamiliarity with EBR/MES, DeltaV, and electronic quality systemsStrong verbal and written communication skillsDemonstrated desire to learn, grow, and develop manufacturing skillsAbility to work effectively in a team-based manufacturing environmentWhat 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 possibleSalary Range70,985.20USD -96,038.80 USD
Worksite address
holly springs, NC, 27540, US
Who can apply
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