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Amgen

Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

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What they do

A Manufacturing Manager plans, schedules, and manages one or more manufacturing production processes. Assists with planning and directing an efficient layout of equipment and flow of materials.

$121,573 / year median in the U.S.

-2% projected decline

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Job Description

Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youveworked 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over10 million patientsworldwide. 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 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. Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days What youwill do Letsdo this.

Letschange the world.

Amgen is seeking aManager ManufacturingDownstreamto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fillwhile partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility. The Manager will play a critical role supporting the design,build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational.

During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm. This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.

As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.

As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.
Responsibilities Frontline Leadership:
Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
Facility Startup & Operational Readiness:
Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
Manufacturing Operations :
Ensure safe, cGMPcompliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
Technology Transfer & Process Implementation:
Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
CrossFunctional Collaboration:
Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.
Compliance & Inspection Readiness:
Maintaininspection readiness and adherence to regulatory and Amgen quality standards.
Continuous Improvement:
Identifyand drive efficiency, reliability, and scalability improvements as operations mature.
Shift Support:
Work nonstandard hours asrequired, transitioning to a 12hour 223 dayshift supporting 24/7 operations. Win What we expect from you We are all different, yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications. Basic Qualifications Doctoratedegree OR Masters degreeand3years ofManufacturing or Operationsexperience OR Bachelors degree and5years ofManufacturing or Operationsexperience OR Associates degree and 10 years of ManufacturingorOperations experience OR High school diploma / GED and 12 years of ManufacturingorOperations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelors degree in Life Sciences or Engineering Experience with facility startup, commissioning, or operational readiness Biologics / drug substance manufacturing experience (downstream) cGMP manufacturing experience (5+ years preferred) Experience with technology transfer and process implementation Prior Area Lead / Specialist / Manager experience Strong leadership, performance management, and conflictresolution skills Solid understanding of regulatory requirements Proficiencywith MES/EBR,DeltaV, Maximo, Veeva, LIMS, 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 annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, Amgen offers a Total Rewards Plancomprisinghealth 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 plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info Website http:
//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States