Process Development Scientist - Commercial Support

Career Category Process Development Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Scientist –  Commercial Support What you will do                                                                                                    Let’s do this. Let’s change the world! In this vital role, you will join the team to provide  support to Amgen’s parenteral manufacturing plant. You will contribute to process monitoring , process improvement, investigations, technology transfers, and other projects that support reliable manufacturing and delivery of life-changing therapies to patients. Specific responsibilities include but are not limited to: Support process monitoring, improvement initiatives, technology transfers, and implementation of data-driven solutions for Formulation, and aseptic Drug Product manufacturing processes. Assist with deviations investigations, root cause analysis, product impact assessment and corrective and preventive action implementation. Author and contribute to technical documents, protocols, reports, presentations, and regulatory-support documentation. Maintain awareness of relevant scientific literature, technology developments, and internal best practices, and communicate observations to project teams. Collaborate cross-functionally with Manufacturing, Quality, Engineering, Process Development, and other internal partners to support commercial manufacturing. Perform  data analysis, and provide technical conclusions, and recommendations to internal teams. Ensure all work is performed in compliance with applicable safety, quality, regulatory, and cGMP expectations. Support department initiatives such as safety programs, continuous improvement activities, , training, and knowledge-sharing forums, as appropriate.  What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Process Development Scientist professional we seek is a collaborative and technically strong individual contributor with these qualifications.

Doctorate degree OR Master’s degree and 2 years of scientific, process development, laboratory, or manufacturing support experience OR Bachelor’s degree and 4 years of scientific, process development, laboratory, or manufacturing support experience Preferred Qualifications: Educational background in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or a related engineering or scientific discipline. Understanding of protein science, formulation and filling processes. Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations. Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills. Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations.