Engineer - Drug Substance Technology & Engineering

Job description

Career CategoryEngineeringJob DescriptionJoin 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. What you will do 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications. Basic Qualifications:Master’s degree OR Bachelor’s degree and 2 years of Process Development experience OR Associate’s degree and 6 years of Process Development experience OR High school diploma / GED and 8 years of Process Development Preferred Qualifications:Master’s degree in Chemical/Biochemical Engineering or related subject area 3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP) Downstream process knowledge and hands on purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance Experience working in/supporting a commercial cGMP manufacturing facility A firm understanding of purification process and related equipment; scale-up from bench to commercial scale, chromatography, viral inactivation, viral filtration, ultrafiltraiton and diafiltration, and impact of process deviations to yield and quality attributes Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations Process development (PD) experience supporting cGMP manufacturing at large scale Strong capability in scientific/engineering/laboratory analysis, trouble shooting and ability to apply sophisticated problem resolution abilities Ability to develop and follow detailed protocols Independently motivated with ability to multi-task and work in teams Excellent written and verbal communication with experience with technical writing and presentations What you can expect of 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 el