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Senior Associate Manufacturing - Product Lifecycle Management

Company: Amgen
Location: West Greenwich
Posted on: January 12, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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 over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Senior Associate Manufacturing-Product Lifecycle ManagementLiveWhat you will doLets do this. Lets change the world. In this vital role you will work within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions to the multi-facility site (AR5 and AR30) and handling the lifecycle of ARIs product portfolio.Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.Shift: Monday-Friday Admin day shiftJob Description:Create and maintain Electronic Batch Records.Drive continuous improvements of MBR System and PLM processes.Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support new product introduction.Develop and maintain the Bill of Materials for each product manufactured at/ transferred to ARI.Support the development of manufacturing sample plans.Develop and maintain User Requirements (URS) for manufacturing equipment.Assist in developing and delivering training materials to manufacturing staff to support new product introduction, product reintroduction, etc.Own and manage change controls, NCs, and CAPAs.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The driven professional we seek is an individual with these qualifications.Basic Qualifications Masters degree OrBachelors degree and 2 years of Manufacturing and Operations experience OrAssociates degree and 6 years of Manufacturing and Operations experience OrHigh school diploma / GED and 8 years of Manufacturing and Operations experiencePreferred Qualifications Manufacturing experience in both upstream and downstream operations.Strong understanding of manufacturing equipment and processes.Experience with SAP and MES.CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.Project Management Skills.Strong analytical and experimental design skills.Excellent verbal and written communication skills.Technical leadership experience.ThriveSome of the vast rewards of working hereAs we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comJoin UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Warwick , Senior Associate Manufacturing - Product Lifecycle Management, Executive , West Greenwich, Rhode Island

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