A on-site role at Amgen.
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Let’s do this. Let’s change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility.
During start up, the Manufacturing Senior Associate Continuous Improvement (CI) Leads will have ownership and oversight of operational readiness activities in manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing. CI leads will support Standard Operating Procedure (SOP) creation, review, and approval; specification and purchasing of required equipment and supplies, design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff. When the plant transitions to operations in 2025 this position will manage and lead the CI program for MFG.
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Provide technical support and subject matter expertise for manufacturing area.
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Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, QMS records, among others.
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Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
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Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility
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Facilitate process, area, and equipment quality risk assessments as needed to identify risks, failure modes, and mitigating actions.
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When the plant is in production, manage the CI program; this includes conducting time studies to identify process inefficiencies, leading improvement projects in designated MFG area (i.e. upstream, downstream, solution prep), implementing proper change management, and tracking sustainment of implemented changes.
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Lead cross-functional CAPAs and EVs as required.
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Serve as a CI and Human and Organizational Performance champion. Provide training to others on CI and lean principles.
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Lead learning team meetings and kaizen events.
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess strong project management and innovative thinking as well as these qualifications.
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High school diploma / GED and 4 years of Manufacturing or Operations experience OR
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Associate’s degree and 2 years of Manufacturing or Operations experience OR
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Bachelor’s degree and 6 months of Manufacturing or Operations experience
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Masters degree
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Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
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Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
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Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff
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Ability to lead small and large cross-functional meetings efficiently.
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Knowledge of process improvement or lean fundamentals.
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Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. The company is ranked 18th on the list of largest biomedical companies by revenue. The name "AMGen" is a portmanteau of the company's original name, Applied Molecular Genetics.
Source: Wikipedia
