Process Development Associate

Basic Qualifications: Bachelor’s degree 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Process Development Associate What You Will Do Perform routine and non-routine GMP analytical testing of synthetic drug substance, drug product, raw materials, stability samples, and other materials as required. Execute testing according to approved analytical methods, specifications, SOPs, protocols, and applicable GMP requirements. Plan and organize laboratory activities to meet testing timelines and business priorities with minimal supervision. Accurately document sample preparation, reagent and standard preparation, instrument conditions, calculations, observations, and results in accordance with GMP and data integrity requirements. Review, analyze, and interpret analytical data to ensure results are scientifically sound, complete, traceable, and reliable. Operate and maintain standard laboratory equipment and analytical instrumentation. Experience with one or more analytical techniques such as HPLC/UPLC, GC, dissolution, UV-Vis, FTIR, Karl Fischer, ion chromatography, wet chemistry, and/or LC-MS is preferred. Troubleshoot analytical methods, instrumentation, sample preparation, and laboratory execution issues and elevate when appropriate. Recognize atypical results, laboratory events, deviations, and potential data-quality issues and promptly communicate them through appropriate GMP processes. Support laboratory investigations, deviations, CAPAs, change controls, method-related assessments, and other quality-system activities as required. Support analytical method transfer, qualification, verification, and validation activities. Effectively transfer analytical procedures into the GMP laboratory and identify scientifically justified modifications or improvements when appropriate. Prepare and review technical documentation, including laboratory notebooks, worksheets, protocols, reports, summaries, and other GMP documentation. Maintain appropriate control and traceability of standards, reagents, solutions, samples, and laboratory materials. Ensure laboratory activities comply with applicable safety requirements, procedures, and regulatory expectations. Communicate testing status, analytical results, technical issues, and potential risks clearly to laboratory management and cross-functional stakeholders. Participate in scientific and technical discussions and provide interpretation of analytical data to the broader project team. Coordinate laboratory resources, instrumentation, materials, and testing activities necessary to complete assigned work. Contribute to continuous improvement efforts focused on laboratory efficiency, compliance, data quality, and operational excellence. Support regulatory inspections, internal audits, and laboratory readiness activities as needed. Train or provide technical guidance to other laboratory personnel when appropriate. Demonstrate sound judgment regarding when independent action is appropriate and when issues require escalation or additional scientific, quality, or management input. 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 go getter with these qualifications. Basic Qualifications: Bachelor’s degree OR Associate’s degree and 2 years of experience OR High school diploma / GED and 4 years of experience Preferred Qualifications Bachelor’s degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline. Approximately 5 years of relevant analytical laboratory experience, preferably within a pharmaceutical or biopharmaceutical GMP environment. Experience performing analytical testing of synthetic pharmaceutical materials is strongly preferred. Working knowledge of GMP requirements, good documentation practices, and laboratory data integrity principles. Demonstrated ability to independently execute analytical procedures and generate accurate, reproducible, and scientifically defensible results. Experience troubleshooting analytical instrumentation and laboratory methods. Ability to effectively organize multiple laboratory activities and meet established testing timelines. Strong written and verbal communication skills with the ability to clearly document and communicate analytical results, laboratory issues, and scientific conclusions. 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. Application deadline 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 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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. #J-18808-Ljbffr Amgen