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Manufacturing MES Lead - Specialist

Company: Amgen
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Career CategoryScientificJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together"researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.MANUFACTURING MES LEAD - SPECIALISTLiveWhat you will doLet's do this. Let's change the world. In this vital role you will act as the Manufacturing Execution Systems (MES) Lead for GMP Drug Substance Supply (DSS). This position is within Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization.ATO DSS is a dynamic environment and an important launch point for Amgen's pipeline products. The GMP DSS plants manufacture drug substance for clinical trials through commercial production using both stainless steel and single-use equipment platforms. This role is a key communication and technical interface function and the Specialist Manufacturing - MES Lead will act as a liaison between the GMP manufacturing operations teams and NPI, Supply Chain, Facilities & Engineering, and Process Development.Job scope and responsibilities:Manufacturing Execution Systems (MES) Lead will be responsible for the design, authoring, implementation and validation of the Electronic Batch Records used in the plants.Directly manage a small team of MES editors.Lead the troubleshooting, problem solving and RCAs associated with MES. Develop and own countermeasures to prevent error recurrence.Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement and data digitization in the plant. Leads integration with data management tools.Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant.Technical expert who leads or participates in projects to introduce new digital technologies into the plant.Represents the plant on global MES network and initiatives.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications.Basic Qualifications:Doctorate degree ORMaster's degree in chemistry, biology, computer science or engineering and 3 years of MES biotechnology operations experience ORBachelor's degree and 5 years of MES biotechnology operations experience ORAssociate's degree and 10 years of MES biotechnology operations experience ORHigh school diploma / GED and 12 years of MES biotechnology operations experiencePreferred Qualifications:Extensive experience with electronic documentation systems in a regulated environmentExperience with PAS X, Werum software with capability to create and edit in EBRExperience in GMP operationsTechnical knowledge of biotechnology cell culture and drug substance purification operationsAbility to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing formsAbility to coach, mentor and/or cross train colleagues within core technical areasBackground in lean manufacturing methodologies and operational excellenceExperience in cross functional Project ManagementExperience validating computer based systemsThriveWhat you can expect of usAs 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.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join Equal Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation..Full timeSDL2017

Keywords: Amgen, Thousand Oaks , Manufacturing MES Lead - Specialist, Other , Thousand Oaks, California

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