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Manufacturing Specialist - MES Lead

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

Job Description:

How has Amgen incorporated diversity, inclusion and belonging into the culture of the company? 0:58 When it comes to diversity, inclusion and belonging, I think there's no better time to be at Amgen than now. The implementation of You Belong Journey, the acknowledgement and celebration of cultural events such as Black History Month. Havin' a D, I, and B department that is distinct from HR. These are a few examples that indicate that our leadership team and Amgen are committed to creating an environment where everyone can feel comfortable being themselves, celebrating their identities and enjoying' what makes them unique. I'm a firm believer that people with different perspectives can make better decisions together. Amgen's actions, energy and responses give me hope that this company is passionate about building' a truly inclusive environment. P Director Bioanalytical Sciences HOW 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 SPECIALIST - MES LEAD Live What you will do Let'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. Win What we expect of you We 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: Master's degree in chemistry, biology, computer science or engineering and 3 years of MES biotechnology operations experience OR Bachelor's degree and 5 years of MES biotechnology operations experience OR Associate's degree and 10 years of MES biotechnology operations experience OR High school diploma / GED and 12 years of MES biotechnology operations experience Preferred Qualifications: Extensive experience with electronic documentation systems in a regulated environment Experience with PAS X, Werum software with capability to create and edit in EBR Experience in GMP operations Technical knowledge of biotechnology cell culture and drug substance purification operations Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Ability to coach, mentor and/or cross train colleagues within core technical areas Background in lean manufacturing methodologies and operational excellence Experience in cross functional Project Management Experience validating computer based systems What you can expect of us As 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 organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Equal Opportunity Statement Amgen 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. Join Us If 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." Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites, social media chat and/or unsolicited emails. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. If you have been the victim of such a scam, please report it to . 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.

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

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