Engineer - Process Development

Engineer - Process Development What you will do Let's do this. Let's change the world. In this vital role you will be responsible for supporting process development and technology transfer of Amgen's drug substance synthetics processes across all phases of development and commercialization. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgen's pipeline. The Engineer will partner with a multi‑functional group of engineers and scientists through the process development cycle at Amgen develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in‑plant support of production operations during process execution and equipment commissioning. Domestic and International Travel: up to 20% The Engineer will be expected to: Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state‑of‑the‑art facilities. Initiate and complete technical tasks in lab, kilo/pilot plant, and manufacturing environments. Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily production or development operations when required to meet schedules or to resolve complex problems. Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution, provide troubleshooting guidance and recommend process improvements. Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements. Communicate and collaborate with Manufacturing, Process Development, and Quality departments. Contribute to key regulatory and quality activities such as non‑conformance, process performance qualification and continued process verification. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications. Basic Qualifications Masters degree Bachelors degree and 2 years of engineering or operations experience Associates degree and 6 years of engineering or operations experience High school diploma / GED and 8 years of engineering or operations experience Preferred Qualifications Academic background in Chemical Engineering 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes Experience in process scale‑up and technology transfer from laboratory to pilot and/or manufacturing scale Basic understanding of cGMP requirements Experience building and utilizing first‑principal models (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 techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc. Background in statistical analysis/DoE Working knowledge of standard plant operations and safety practices Excellent project management skills Strong verbal communication and presentation skills Benefits 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. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.