Process Development Sr. Scientist

Process Development Senior Scientist In this vital role you will support Amgen’s diverse early‑stage therapeutic portfolio by characterizing process and product properties of large‑molecule drug candidates and assessing the quality attributes of protein therapeutics across multiple pipeline areas. Responsibilities Provide analytical leadership for pre‑pivotal programs, applying advanced analytical techniques to characterize novel modalities in development. Serve as the Attribute Sciences representative on cross‑functional project teams and collaborate effectively with scientists from multidisciplinary teams. Design experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics. Apply advanced analytical methods—including CE, SEC, IEX, RP, HILIC and mass spectrometry—to characterize protein therapeutics. Evaluate analytical method performance and reliability, including the impact of proposed method changes. Support drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities. Author regulatory documents and apply knowledge of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability. Stay current in the field and evaluate emerging analytical technologies. Basic Qualifications Doctorate degree (PhD, PharmD, or MD) with relevant post‑doc experience; or Master’s degree and 3 years of directly related life‑science experience; or Bachelor’s degree and 5 years of directly related life‑science experience. Preferred Qualifications PhD in analytical chemistry, biochemistry, biophysics, or a related life‑science field with 2 years of industry experience. Strong expertise in developing, qualifying, and troubleshooting analytical methods using HPLC/UPLC, CE, mass spectrometry, and related technologies to characterize protein therapeutics. Proven experience in separation sciences, protein chemistry, and/or mass spectrometry. Strong laboratory skills including experimental design and execution, complex data interpretation, and timely delivery of results. Familiarity with common therapeutic protein quality attributes such as fragmentation, deamidation, oxidation, and partial reduction, and tools used for their characterization and quantification. Experience with GMP compliance. Ability to work independently to advance projects and studies within required timelines. Excellent written and verbal communication skills, with the ability to document, present, and discuss scientific results in a fast‑paced, multidisciplinary environment. Benefits and Compensation Expected annual salary range: USD 126,066 – 170,560. The Total Rewards Plan includes health and welfare plans for staff and eligible dependents, a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, a discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where applicable. Equal Opportunity Employer 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 Amgen Inc. (IR)