Upstream Drug Substance Specialist — Process Owner

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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. Specialist Manufacturing Associate What You Will Do Let’s do this. Let’s change the world. In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgen’s pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production. We are seeking an experienced Specialist for the Manufacturing Team to execute a variety of production and process related changes to operations in a large-scale manufacturing plant. This Specialist will own corrective and preventative projects that are implemented into the manufacturing plant. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective/preventive actions and implementing them. Some ‘hands-on’ work on the plant floor executing runs and experiments, working with large-scale equipment, analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices, ensuring documentation accurately reflects operations performed, implementing area improvements, commissioning equipment, design of experiments, effectively communicating findings and participating in operations meetings. Responsibilities: Support manufacturing by providing subject-matter expertise for drug substance upstream as process owner (PPO) Lead cross-function and complex projects using project management skills. Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process. Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management. Own Quality Records, such as CCMS, CAPA, and CAPA-EV. Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant. Demonstrate strategic problem-solving skills and champion continual improvement. Present to inspectors on areas of expertise. Mentor and train junior staff. Ability to be on-site (flexible worker) Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations. Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance. As Process owner: Lead operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills Provide assessment and advice on process impact for changes Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies. . What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a team-player partner with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of manufacturing and or operations experience OR Bachelor’s degree and 4 years of manufacturing and or operations experience OR Associate’s degree and 8 years of manufacturing and or operations experience OR High school diploma / GED and 10 years of manufacturing and or operations experience Preferred Qualifications: Degree in Engineering or Life Sciences 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent. Technical knowledge of drug substance processing and broad understanding of related disciplinary areas Ability to navigate through ambiguity and identify and deliver on key milestones. Ability to advise and influence using experience and data. Ability to successfully 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 area. Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities. Ability to drive results through leadership of cross-functional teams Experience leading and managing projects Understanding of single-use technologies Data analysis and/or data visualization skills Excellent writing skills. Presentation experience – presentation to leadership or auditors. Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively Proficiency in Smartsheet and excel, Trackwise, Visio, pi, SAP, Spotfire What You Can Expect From 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. 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. 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. #J-18808-Ljbffr Amgen