Sr Engineer

About the role

Join Amgens 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 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.

Responsibilities

• Provide technical leadership to Amgens parenteral drug product process design and commercialization
• Lead off-line process characterization activities and work with global technology transfer team to transfer the process to clinical/commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required
• Play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support development of silico models to enable rapid, robust process development
• Operate and troubleshoot filling equipment for characterization, special studies, and/or material generation to support the Amgen network
• Design, implement, and document technical data packages related to drug product process design, development, and characterization
• Meticulously review protocols and study design to streamline execution and ensure successful implementation
• Support development of models and other data analytic tools for rapid process development and tech transfer
• Drive innovations in drug product process characterization and reduce pilot plant and clinical/commercial GMPL timeline required for successful technology transfers and NPIs
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to solve issues, improve, and develop new processes and evaluate effects of equipment changes, scale, and implementation of new raw materials
• Serve as an authority on manufacturing technologies (e.g., filling, automated visual inspection) and work with global multi-functional teams to develop and improve shared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants
• Apply strong written and verbal communication skills. Author technical protocols, reports, and present findings and project status
• Contribute to and maintain a strong culture of safety and compliance in the plant
• Travel domestically and internationally may be required

Requirements

• Doctorate or Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 8 years of Engineering experience OR High School Diploma/GED and 10 years of Engineering experience

Preferred Qualifications

• Advanced degree in engineering, biotechnology, lifesciences, or related subject area
• 2+ years experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfer to manufacturing sites
• Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations
• Hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, visual inspection operation, etc.)
• Ability to lead innovation, collaborate in a multi-functional team, and act on dynamic information at a rapid pace
• Experience designing and completing characterization studies, authoring characterization protocols, process transfer documents, and technical reports
• Strong problem-solving, critical thinking, and the delivery of technical solutions with limited oversight
• Organizational and communication skills to enable business decisions
• Demonstrated skills in leading diverse multi-functional projects