Engineer - Drug Substance Technology & Engineering

Engineering Job Description

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.

Let's do this! Let's change the world! Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities, from training and education to expanding current job responsibilities. Amgen is seeking an Engineer to join the Drug Substance Technology & Engineering (DSTE) team at our Thousand Oaks, California site. In this onsite role, you will provide downstream purification process engineering support for a diverse portfolio of both clinical and commercial biologics drug substance products across the network. The Engineer will provide technology transfer, process validation, and manufacturing support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing processes in a cGMP environment. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen's Thousand Oaks site. Responsibilities include but are not limited to: · Transfer purification drug substance processes and process improvements from the laboratory to manufacturing facilities and between manufacturing sites. · Provide solutions to technical problems of moderate scope and complexity. · Evaluate, select, and apply standard engineering techniques and procedures under general supervision; seek assistance when addressing unusual problems. · Support process validation for late-stage commercial processes. · Provide on-the-floor technical support for process scale-up and technology transfer, as well as clinical and commercial manufacturing operations. · Perform routine and nonroutine process monitoring and troubleshooting. · Support nonstandard shift schedules and extended hours as business needs require. · Trend process data and perform statistical analyses. · Provide technical input for process-related deviations (NCs), CAPAs, and change controls. · Identify and support process-related operational excellence and continuous improvement opportunities, including efforts to improve efficiency across business process workstreams. · Represent Process Development and collaborate with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams to develop requirements and recommendations for process or system modifications. · Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality. · Complete assignments with clear objectives that require investigating a limited number of variables. · Serve as a technical expert for equipment and systems troubleshooting, becoming actively involved in daily operations as needed to meet schedules or resolve complex problems. · Apply engineering principles and statistical methods, including design of experiments, to resolve processing issues and evaluate process improvement opportunities.

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

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 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.

We highly recommend utilizing Workday's robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the "Upload My Experience" functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile. Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a "Partially Meets Expectations" or higher. Please visit our Internal Transfer Guidelines for more detailed information. .

88,281.00USD -119,439.00 USD