Sr. Engineer, Process Development

Career Category Engineering 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. 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. 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. Sr Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for authoring technical reports, leading risk assessments, and contributing to regulatory documents through all phases of technology transfer and commercialization. Position located in either Cambridge, MA or Thousand Oaks, CA. Domestic and International Travel: up to 20% Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes. Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements necessary to ensure safe and successful scale-up and tech transfer. Design, optimize, and deploy process models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations. Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts. Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation. Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline, such that key milestones are established and achieved. Apply standard and advanced engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up. Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance. Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer. Author, review and/or approve of process documentation needed for process validation and commercialization activities. Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification. Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making. Lead or represent department as subject matter expert for process risk analysis. Work closely with process development chemists, formulation scientists, and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree 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: Familiar with bioprocessing unit operations required to support ADCs and/or oligonucleotides, including conjugation and purification. Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, and productivity. Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities. Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports. Experience building and utilizing first-principles models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms. Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc. Experience using data science and/or advanced statistical analysis to solve processing issues and evaluate opportunities for process improvements. Proficient understanding of regulatory and cGMP requirements. Command of lab and plant operations and associated safety practices. Familiarity with HPAPI processing and containment. Engineering knowledge around linker payload chemistry and scale-up. Strong communication and presentation skills 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 i